Clinical Research

Brainsway’s TMS therapy tests

Brainsway’s TMS therapy eligible

TMS treatment session

CE indications for Brainsway Deep TMS

Chances of improvement using Brainsway TMS Therapy

TMS treatment compare with ECT

TMS treatment side effects or risks

TMS therapy side effects or risks

TMS treatment compare with ECT

TMS treatment

CE indications for Brainsway Deep TMS

TMS therapy tests

The difference between different types of medication and TMS therapy

TMS treatment session

The BrainsWay Advantage for Treatment Resistant Depression Patients

New Hope for Your Post Traumatic Stress Disorder (PTSD)

Need help with your smoking addiction?

New Hope for Bipolar Patients

Evaluation of Deep TMS as an Aid to Smoking Cessation

Stroke Rehabilitation – Double-Blind Placebo Control Safety and Feasibility Study

A Randomized Sham-Controlled Study of H-Coil Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Late-Life Depression

Controlled trial of 1 Hz Deep transcranial magnetic stimulation for treatment of temporal lobe epilepsy

Alzheimer’s Disease – Double-Blind Placebo Control Safety and Feasibility Study

A Pilot Study to Determine the Safety and Efficacy of H-Coil Deep Transcranial magnetic Stimulation in treatment resistant Anorexia Nervosa

New Hope for Your Major Depressive Disorder (MDD)

New Hope for Neuropathic Pain Patients

BrainsWay D (TMS) Therapy for Depression – What to Expect, from Start to Finish

Insomnia Caused by Antidepressants – Problems and Solutions

BrainsWay Therapy or Antidepressants?

Add-on deep transcranial magnetic stimulation (dTMS) in patients with dysthymic disorder comorbid with alcohol use disorder: A comparison with standard treatment.

Girardi P1, Rapinesi C, Chiarotti F, Kotzalidis GD, Piacentino D, Serata D, Del Casale A, Scatena P, Mascioli F, Raccah RN, Brugnoli R, Digiacomantonio V,Ferri VR, Ferracuti S, Zangen A, Angeletti G. World J Biol Psychiatry. 2014 Aug 20:1-8.

The study compared standard drug treatment (n=10) with drug treatment combined with Brainsway® Deep TMS (Transcranial Magnetic Stimulation ; n=10) for treating mood and substance use disorders through stimulation of the Dorsolateral prefrontal cortex (DLPFC). The study, held over 6 months, included abstinent patients suffering from Alcohol Use Disorder, who also had a previous dysthymic disorder. The study showed that after 20 sessions of Deep TMS, craving and depressive symptoms dropped significantly, suggesting that Brainsway’s Deep TMS is well tolerated and effective as an add-on treatment for alcohol use disorder.

Alcohol and suicidality: could deep transcranial magnetic stimulation (dTMS) be a possible treatment?

Rapinesi C1, Kotzalidis GD, Scatena P, Del Casale A, Janiri D, Callovini G, Piacentino D, Serata D, Raccah RN, Brugnoli R, Digiacomantonio V, Mascioli F,Ferri VR, Ferracuti S, Pompili M, De Pisa E, Di Pietro S, Zangen A, Angeletti G, Girardi P., Psychiatr Danub. 2014 Sep;26(3):281-4.

A 56-year-old man experienced anxiety, depression, sexual dysfunction, suicidal thoughts and alcohol intake of up to 1.5 liters a day. In this case study, the patient received 20 sessions of Brainsway® Deep TMS (Transcranial Magnetic Stimulation) over a period of a month. After the 7th session, anxiety, panic-like symptoms and craving for drinking disappeared. After the 11th session, suicidal thoughts decreased, and after the final session the patient showed various improvements, including increased libido and decreased depressive symptoms. At the 6-month follow-up, he did not resume drinking, had no craving for alcohol and no suicidal thoughts.

Add-on deep transcranial magnetic stimulation (dTMS) in patients with dysthymic disorder comorbid with alcohol use disorder: A comparison with standard treatment.

Girardi P1, Rapinesi C, Chiarotti F, Kotzalidis GD, Piacentino D, Serata D, Del Casale A, Scatena P, Mascioli F, Raccah RN, Brugnoli R, Digiacomantonio V,Ferri VR, Ferracuti S, Zangen A, Angeletti G. World J Biol Psychiatry. 2014 Aug 20:1-8.

The study compared standard drug treatment (n=10) with drug treatment combined with Brainsway® Deep TMS (Transcranial Magnetic Stimulation ; n=10) for treating mood and substance use disorders through stimulation of the Dorsolateral prefrontal cortex (DLPFC). The study, held over 6 months, included abstinent patients suffering from Alcohol Use Disorder, who also had a previous dysthymic disorder. The study showed that after 20 sessions of Deep TMS, craving and depressive symptoms dropped significantly, suggesting that Brainsway’s Deep TMS is well tolerated and effective as an add-on treatment for alcohol use disorder.

Add-on deep transcranial magnetic stimulation (dTMS) in patients with dysthymic disorder comorbid with alcohol use disorder: A comparison with standard treatment.

Girardi P1, Rapinesi C, Chiarotti F, Kotzalidis GD, Piacentino D, Serata D, Del Casale A, Scatena P, Mascioli F, Raccah RN, Brugnoli R, Digiacomantonio V,Ferri VR, Ferracuti S, Zangen A, Angeletti G. World J Biol Psychiatry. 2014 Aug 20:1-8.

The study compared standard drug treatment (n=10) with drug treatment combined with Brainsway® Deep TMS (Transcranial Magnetic Stimulation ; n=10) for treating mood and substance use disorders through stimulation of the Dorsolateral prefrontal cortex (DLPFC). The study, held over 6 months, included abstinent patients suffering from Alcohol Use Disorder, who also had a previous dysthymic disorder. The study showed that after 20 sessions of Deep TMS, craving and depressive symptoms dropped significantly, suggesting that Brainsway’s Deep TMS is well tolerated and effective as an add-on treatment for alcohol use disorder.

Bipolar Disorder – Double-Blind Placebo Control Safety and Feasibility Study

Shalvata Mental Health Center, Hod-Hasharon, Israel

13 January, 2009

A double-blinded and placebo-controlled clinical trial has begun at the Shalvata Mental Health Center to explore the efficacy and safety of Braisnway® Deep TMS in 50 subjects with bipolar depression, currently treated with mood stabilizers and previously unsuccessfully treated with antidepressant medication.

The trial is expected to be carried out over the course of 7 weeks in respect of each subject.

This trial is expected to serve as the basis for a broad multi-center trial.

Brainsway Deep TMS add-on treatment for intractable Tourette syndrome: A feasibility study

Bloch, Y., Arad, S., & Levkovitz, Y. (2014). World Journal of Biological Psychiatry, (Epub ahead of print).

This study explores the effect of Brainsway® Deep TMS (Transcranial Magnetic Stimulation) on adults who suffer from intractable Tourette Syndrome (TS). The study enrolled 12 patients and was held over 20 days. The study found no significant side effects, and indicated that Deep TMS is safe for treating TS. In the study, the subgroup who suffered from both TS and Obsessive Compulsive Disorder (OCD) experienced significant improvement – a beneficial result that also indicates that TS is not of a uniform nature.

Cognitive – emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome

Isserles, M., Rosenberg, O., Dannon, P., Levkovitz, Y., Kotler, M., Deutsch, F., & Zangen, A. (2011). Journal of affective disorders, 128(3), 235-242.

This study examined the effect of the Transcranial Magnetic Stimulation H-coil on patients suffering from depression, following positive or negative emotional triggering. This was done by focusing the patients on either positive or negative thoughts or emotions associated with the patient’s depression. In this study, it was demonstrated that positive, rather than negative, emotional triggering prior to brain stimulation using the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil results in more favorable treatment outcomes.

A coil design for transcranial magnetic stimulation of deep brain regions.

Roth, Y., Zangen, A., & Hallett, M. (2002). Journal of Clinical Neurophysiology, 19(4), 361-370.

This paper introduces, for the first time, the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil. The paper illustrates the considerations relevant to the design of the coil and compares the H-coil to a standard coil using a model of the human head. The study demonstrates that the electric field generated by the H-coil decays at a much slower pace than the electric field generated by the standard coil, indicating the H-Coil’s deeper penetration of the brain.

Cooperation with Institutions for Deep Transcranial Magnetic Stimulation

Brainsway® runs clinical research programs with leading scientists worldwide, collaborating with prominent institutions and researchers in clinical trials covering various neuropsychiatric and neuroscience applications for deep transcranial magnetic stimulation.

Deep Repetitive Transcranial Magnetic Stimulation Associated With Improved Social Functioning in a Young Woman With an Autism Spectrum Disorder

Enticott, P. G., Kennedy, H. A., Zangen, A., & Fitzgerald, P. B. (2011). The journal of ECT, 27(1), 41-43.

This case report examines the effect of Brainsway® Deep TMS (transcranial magnetic stimulation) in a patient with autism. In the case report, high-frequency stimulation was administered for 15 minutes per session, 9 treatments over 11 days. In this patient, social and interpersonal communications abilities were improved following treatment, as noted both by the patient and by her family. The conclusions were that Deep Transcranial Magnetic Stimulation in ASD can improves several facets of cortical dysfunction.

Deep repetitive transcranial magnetic stimulation with H-coil on lower limb motor function after stroke: A pilot study

Chieffo, R., De Prezzo, S., Houdayer, E., Nuara, A., Di Maggio, G., Coppi, E., & Leocani, L. (2014). Archives of physical medicine and rehabilitation.

This study examined the effect of Brainsway® Deep TMS (Transcranial Magnetic Stimulation) on patients that suffer from stroke-induced impairment of the lower limb motor function. There were two treatment periods, each comprising 11 sessions over 3 weeks, and separated by a 4-week period. The study showed that Deep TMS could generate long-term improvements in the functioning of the lower limb. In this study it was demonstrated that Brainsway Deep Transcranial Magnetic Stimulation results in significant and long lasting alleviation of symptoms.

Deep Repetitive Transcranial Magnetic Stimulation for Smoking Cessation: Is Going Deeper Better?

Barr, M. S., & George, T. P. (2014). Biological Psychiatry, 1;76(9):678-80.

This report describes a double-blind, sham-controlled trial that used the Brainsway Deep TMS (Transcranial Magnetic Stimulation) H-Coil for smoking cessation. It was found that, when applied bilaterally on the dorsolateral prefrontal cortex (DLPFC) and insular cortex, the H-coil may decrease short-term biochemically verified smoking and nicotine dependence levels and increase short- and long-term smoking abstinence rates.

Deep TMS as an Add On for Anti Depressant Medications in MDD

Hadassah Ein-Kerem Medical Center, Jerusalem, and Be'er Ya'akov Mental Health Center, Israel

6 August 2009

clinical trial of studying the feasibility of using the Deep TMS H System in augmentation of antidepressant drugs, for the treatment of resistant depression, took place at the Hadassah Ein-Kerem Medical Center, Jerusalem, and Be’er Ya’akov Mental Health Center, Israel.

Deep TMS is found Safe and Effective for the Treatment of ADHD

Results demonstrate a substantial therapeutic advantage for deep and widespread stimulation using Brainsway’s proprietary ADHD coil over superficial stimulation with a standard figure-8 coil

Brainsway® Ltd. (TASE: BRIN), a leader in non-invasive brain stimulation, is pleased to announce final results from a phase II clinical study investigating the efficacy of Deep transcranial magnetic stimulation (Deep TMS) using a specialized electromagnetic coil developed for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. The study was conducted at the Soroka University Medical Center in Beer Sheva, Israel, in collaboration with the Ben Gurion University, and was led by Principal Investigators Dr. Hadar Shalev and Prof. Abraham Zangen.

Deep TMS in a resistant major depressive disorder: a brief report

Rosenberg, O., Shoenfeld, N., Zangen, A., Kotler, M., & Dannon, P. N. (2010). Depression and anxiety, 27(5), 465-469.

his study examined the effect of the Brainsway® Deep Transcranial Magnetic Stimulation H-coil as an add-on treatment for patients suffering from drug-resistant depression. The study comprised depression patients, and treated them with Brainsway Deep Transcranial Magnetic Stimulation H1-coil, which was connected to a Magstim rapid 2 stimulator. In the study, the average HDRS and average Hamilton Anxiety Rating Scale score decreased. In this study it was demonstrated that using Deep TMS as an add-on treatment results in significant alleviation of symptoms.

Deep TMS Treatment for Bipolar Disorder

Deep TMS Treatment for Bipolar Disorder

Shalvata Medical Health Center, Hod-Hasharon, Israel

2 October 2008

A clinical trial of studying the feasibility of using the Deep TMS H System for treating bi-polar disorder episodes, took place at the Shalvata Mental Health Center, Hod-Hasharon, Israel.

Brainsway Ltd. announces the final results of a clinical trial utilizing the Company’s Deep TMS device for the treatment of Bipolar Depression (Manic Depression) in subjects that did not respond to medication, as such results was presented in a conference on the matter that was held in Germany. The trial was performed in Shalvata hospital in the framework of a collaborative effort between the Company and the hospital, and its objective was to investigate treatment utilizing the Company’s Deep TMS device.

Deep TMS treatment for Negative Symptoms in Schizophrenia

Shalvata Mental Health Center, Hod-Hasharon, Israel

10 March 2008

A clinical trial using the Deep TMS H System to treat schizophrenic patients, began in August 2006 at the Shalvata Mental Health Center, Hod-Hasharon, Israel.

In a recent ongoing open trial, feasibility safety and efficacy of the H1 coil in the treatment of negative symptoms and cognitive deficits is studied at the Shalvata Mental Health Center.

Deep TMS treatment in Schizophrenia – Auditory Hallucinations

Be'er Ya'akov Mental Health Center, Be'er Ya'akov, Israel

3 January 2010

Brainsway is pleased to announce its final results from a clinical trial of the Company’s Deep TMS device for the treatment of auditory hallucinations in schizophrenic patients. The trial was performed at the Be’er Ya’akov Mental Health Center in the framework of a collaboration between Brainsway, the Be’er Ya’akov Mental Health Center and the Medical Research Fund of the Assaf Harofeh Hospital.

Deep transcranial magnetic stimulation add-on for treatment of negative symptoms and cognitive deficits of schizophrenia: A feasibility study

Levkovitz, Y., Rabany, L., Harel, E. V., & Zangen, A. (2011). The International Journal of Neuropsychopharmacology, 14(07), 991-996.

This study examined the effect of Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil stimulation on schizophrenic patients. In the study, patients were given 20 daily Deep Transcranial Magnetic Stimulation sessions over the prefrontal cortex. The study demonstrated that brain stimulation using the H-coil significantly alleviates the negative symptoms of schizophrenia as well as enhancing cognition.

Deep transcranial magnetic stimulation (DTMS) in the treatment of major depression: An exploratory systematic review and meta-analysis

Kedzior, K. K., Gellersen, H. M., Brachetti, A. K., & Berlim, M. T. (2015). Journal of Affective Disorders, 187:73–83

This review and meta-analysis paper concerns the acute effect of Brainsway® Deep TMS (Deep Transcranial Magnetic Stimulation) on major depressive disorder (MDD). The review included 9 open label studies enrolling mostly treatment resistant MDD patients. Analysis was conducted for the treatment’s effect, based on the accepted depression rating scale (HDRS), and the rate of responders, patients that achieved remission, and patients that did not complete the experiment (dropouts).

The study found that high-frequency stimulation over 20 sessions led to a significant alleviation of the depressed state in the majority of patients; and it was suggested that employing Deep TMS as an add-on to concurrent medication may increase the effectiveness of both treatments.

Deep transcranial magnetic stimulation over the prefrontal cortex: Evaluation of antidepressant and cognitive effects in depressive patients

Levkovitz, Y., Harel, E. V., Roth, Y., Braw, Y., Most, D., Katz, L. N., & Zangen, A. (2009). Brain Stimulation, 2(4), 188-200.

This is the first clinical study using the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil for deep brain stimulation. This large scale study examined the effect of H-coil on patients suffering from drug-resistant depression. The study found a significant improvement in HDRS scores in the cases of high-intensity stimulation.  The study demonstrated that brain stimulation using the Brainsway Deep TMS H-coil results in significant alleviation of depressive symptoms in these patients.

Deep transcranial magnetic stimulation for the treatment of auditory hallucinations: a preliminary open-label study

Rosenberg, O., Roth, Y., Kotler, M., Zangen, A., & Dannon, P. (2011). Annals of general psychiatry, 10(1), 3.

This study examined the effect of Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil stimulation on auditory hallucinations of schizophrenic patients. Low-frequency Deep TMS was used to stimulate the left temporoparietal cortex over 10-20 sessions. The study showed a substantial improvement in HRS score as well as a smaller improvement in SAPS. The study demonstrated that Deep Transcranial Magnetic Stimulation using the H-coil significantly alleviates positive symptoms of schizophrenia.

Deep transcranial magnetic stimulation as a treatment for psychiatric disorders: A comprehensive review

Bersani, F. S., Minichino, A., Enticott, P. G., Mazzarini, L., Khan, N., Antonacci, G., & Biondi, M. (2013). European Psychiatry, 28(1), 30-39.

This paper reviews the work done so far using the Brainsway® Deep TMS (Deep Transcranial Magnetic Stimulation) H-coil, and demonstrates the biological and physical components that participate in the effects generated by Deep Transcranial Magnetic Stimulation; both in general terms and for specific psychiatry disorders.

Deep Transcranial Magnetic Stimulation for treatment-resistant bipolar depression: A case report of acute and maintenance efficacy

Bersani, F. S., Girardi, N., Sanna, L., Mazzarini, L., Santucci, C., Kotzalidis, G. D., & Girardi, P. (2013). Neurocase, 19(5), 451-457.

This case report examines the effect of Brainsway® Deep TMS (Deep Transcranial Magnetic Stimulation) H-coil stimulation in a patient with bipolar depression. The patient was provided with 20 daily consecutive Transcranial Magnetic Stimulation sessions, as well as one session every 2 weeks, over 3 months after the initial treatment. In this patient, symptoms were significantly alleviated and cognition was significantly enhanced following treatment. Moreover, these beneficial effects were evident for 6 months post treatment.

Differential effects of deep TMS of the prefrontal cortex on apathy and depression‏

Levkovitz, Y., Sheer, A., Harel, E. V., Katz, L. N., Most, D., Zangen, A., & Isserles, M. (2011). Brain stimulation, 4(4), 266-274.

This study examined the effect of the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil stimulation on depressed patients, and evaluated separately the effect on depressive symptoms and on one of depression’s core symptoms – apathy. In the study, antidepressant medication treatment was ceased, and Deep Transcranial Magnetic stimulation was given 5 days a week, over 4 weeks. The study demonstrated that brain stimulation using the Deep TMS H-coil significantly alleviates depressive symptoms including apathy, but only if pre-treatment apathy was not very severe

A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device – Efficacy and Safety in Subjects with ADHD

Shalvata Mental Health Center, Israel

6 March 2013

The purpose of the study is to explore the efficacy and safety of HBLPADD Coil Deep TMS in subjects with ADHD. The Patient Population is 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.

Double-blind, randomized sham controlled study of deep-TMS add-on treatment for negative symptoms and cognitive deficits in schizophrenia

Rabany, L., Deutsch, L., & Levkovitz, Y. (2014). Journal of Psychopharmacology, 4;28(7):686-690.

The study examined Brainsway® Deep TMS (Transcranial Magnetic Stimulation) as an add-on treatment for negative symptoms and cognitive deficits in schizophrenia. In the study, 30 patients were randomly assigned to receive real or sham Deep TMS (20 sessions), where both patients and operators were not aware of the type of treatment. In the study, negative symptoms significantly decreased in the group that received real Deep TMS treatment.

Double Blind Sham Control study of Deep TMS in Neuropathic Pain

Sapienza University of Rome, Italy

26 June, 2011

Further to that stated in Brainsway®’s periodic report for 2010 regarding the double-blinded clinical trial for the treatment of diabetic chronic neuropathic pain that was conducted by Advanced Technologies Innovation Distribution SRL (“Atid”) in Italy using the Company’s Deep TMS device, the Company is pleased to announce the final results of the trial, which was performed on 33 subjects, with each subject receiving a series of REAL treatments over five days, and a series of SHAM treatments over five days. The time gap between these series was 45 days, and the order of REAL and SHAM treatments was randomized.

Double Blind Sham Control study of Deep TMS in NIH (Blepharospasm)

National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA

24 October, 2010

Further to that stated in Brainsway®’s periodic report for 2009, the Company is pleased to announce that analysis of the results of the clinical trial of the Company’s Deep TMS device for the treatment of the symptoms of blepharospasm (a disorder that affects the eye muscles and causes uncontrolled blinking), reveals that low-frequency Deep TMS treatment using the specialized H-BL TMS coil developed by the Company or using a C-coil (a coil employed in TMS studies), is safe and it leads to immediate alleviation of blepharospasm symptoms. The trial followed a double-blind design with a control group, and was performed by researchers from the National Institute of Neurological Disorders and Stroke (NINDS) research division of the NIH, headed by Dr. Mark Hallett.

Effectiveness of deep transcranial magnetic stimulation combined with a brief exposure procedure in post-traumatic stress disorder – A pilot study

sserles, M., Shalev, A. Y., Roth, Y., Peri, T., Kutz, I., Zlotnick, E., & Zangen, A. (2013). Brain stimulation, 6(3), 377-383.

This study examined the effect of Brainsway® Deep TMS (Transcranial Magnetic Stimulation) on PTSD patients, following activation of the traumatic memory. In this double-blind study, patients who received real stimulation showed substantial improvement in the intrusive component of the CAPS scale, after exposure to the traumatic event script. The study demonstrated that the H-coil significantly alleviated PTSD symptoms following memory activation, but not following non-provoked or sham stimulations.

Effectiveness of a second deep TMS in depression: A brief report

Rosenberg, O., Isserles, M., Levkovitz, Y., Kotler, M., Zangen, A., & Dannon, P. N. (2011). Progress in Neuro-Psychopharmacology and Biological Psychiatry, 35(4), 1041-1044.

This study examined the effect of the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil stimulation on depressed patients which previously benefited from the treatment but suffered from deterioration. The patients were given 20 daily sessions of stimulation, resulting in a significant decrease in HDRS, HARS and BDI scores, although at a lesser rate compared to the decrease during the first Deep TMS treatment period. In this study it was demonstrated that a second treatment period of brain stimulation using the H-coil significantly alleviates depressive symptoms.

Evaluation of the H1-Coil Transcranial Magnetic Stimulation (TMS) Device – Safety and Feasibility study for Treatment of Major Depressive Episode in the elderly

Shalvata Mental Health Center, Israel

11 March 2012

The purpose of this study is to evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode.

Excitatory Deep Transcranial Magnetic Stimulation With H-Coil Over the Right Homologous Broca’s Region Improves Naming in Chronic Post-stroke Aphasia

Chieffo, R., Ferrari, F., Battista, P., Houdayer, E., Nuara, A., Alemanno, F., & Leocani, L. (2013). Neurorehabilitation and neural repair, 1545968313508471.

This study was designed to examine the effect of different stimulation frequencies on the inability to use spoken language due to a stroke-induced brain lesion. Patients were tested for their ability to correctly name a picture following either high, low, or sham stimulation. This study demonstrated that acute, high-frequency, brain stimulation using Brainsway® Deep TMS, or Deep Transcranial Magnetic Stimulation, significantly improves stroke-induced inability to use spoken language.

H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy

Onesti, E., Gabriele, M., Cambieri, C., Ceccanti, M., Raccah, R., Di Stefano, G., & Inghilleri, M. (2013). European Journal of Pain, 17(9), 1347-1356.

The study examined the effect of stimulation on pain sensation and joint bending reflex in patients with diabetic-induced pain. During two one-week treatment periods, separated by 5 weeks, patients received either real or sham stimulation. In this study it was demonstrated that brain stimulation using the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil, but not sham stimulation, significantly improved results in both measurements. Moreover, these beneficial effects were still present in the 3 week follow-up session.

H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibility study

Harel, E. V., Zangen, A., Roth, Y., Reti, I., Braw, Y., & Levkovitz, Y. (2011). World Journal of Biological Psychiatry, 12(2), 119-126.

This study examined the effect of the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil as an add-on treatment for patients suffering from bipolar depression. In the study, bipolar depression patients who were under medication treatment received daily rTMS for four consecutive weeks. The study demonstrated that adding brain stimulation using the Brainsway Deep TMS H-coil results in significant alleviation of symptoms.

H-coil repetitive transcranial magnetic stimulation for treatment resistant major depressive disorder: An 18-week continuation safety and feasibility study

Harel, E. V., Rabany, L., Deutsch, L., Bloch, Y., Zangen, A., & Levkovitz, Y. (2014). The World Journal of Biological Psychiatry, 15(4), 298-306.

This study examined the long-term effect of Brainsway® Deep TMS (Deep Transcranial Magnetic Stimulation) on depressed patients. Patients underwent 4 weeks of intensive treatment and 18 weeks of maintenance treatments. The study demonstrated that brain stimulation using Brainsway’s Deep Transcranial Magnetic Stimulation significantly alleviates depressive symptoms, and that this beneficial effect can be maintained for a long period of time.

Long Term Effect of Maintenance of Deep TMS Treatment in MDD

Shalvata Mental Health Center, Hod Hasharon, Israel

Further to Brainsway’s periodic report for 2009 regarding the maintenance treatment clinical trial performed by the Company on patients who responded to the previous clinical trial of the Deep TMS device for acute treatment of drug-resistant major depression, the Company is pleased to announce that final results in respect of 30 patients have been obtained.

Major Depression – Multicenter Double Blind Randomized Controlled Trial for Tolerability, Safety and Efficacy of the H-Coil Deep TMS – Completed

22 medical centers in the USA, Canada, Europe and Israel

16 September, 2009

A multicenter clinical trial for the assessment of the efficacy and safety of Brainsway® Deep TMS in subjects suffering from major depression disorder (MDD) took place in 22 medical centers in the USA, Canada, Europe and Israel.

The purpose of the study was to evaluate the efficacy and safety of Brainsway Deep TMS, in subjects suffering from Major Depressive Disorder who have been unsuccessfully treated with antidepressant medication.

The study, which took place over 16-weeks, is a Double-Blind Placebo-Controlled study which enrolled over 230 subjects. The results showed a profound decline in HDRS-21 and significant remission (32.6%) and response (38.4%) rates at the primary endpoint of the study. Brainsway treatment was proved to be safe, as the treatment was well tolerated by the majority of the study subjects.

Following this study, the FDA*  granted Brainsway a wide indication for the treatment of Depression patients who did not benefit from any number of previous medication treatments.

* FDA 510(k) No. K122288

Multiple Sclerosis – Double-Blind Placebo Control Safety and Feasibility Study

Charité University, Berlin, Germany; University Medical Center Hamburg-Eppendorf, Hamburg, Germany

21 March, 2010

A clinical trial of Brainsway®’s Deep TMS for the treatment of multiple sclerosis patients (MS) has begun in two leading medical centers in Germany: the Charité Hospital – considered to be the leading university hospital in Berlin, and the University Medical Center Hamburg-Eppendorf, in Hamburg.

Retrospective Evaluation of Deep Transcranial Magnetic Stimulation as Add-On Treatment for Parkinson’s Disease

Torres F, Villalon E, Poblete P, Moraga-Amaro R, Linsambarth S, Riquelme R, Zangen A. and Stehberg J. Retrospective Evaluation of Deep Transcranial Magnetic Stimulation as Add-On Treatment for Parkinson’s Disease. Front Neurol. 2015; 6: 210.

The study examined the effectiveness of Brainsway® Deep TMS as an add-on treatment for Parkinson’s patients who are regularly treated with medication but show insufficient response to the standard medications. The study included 45 Parkinson’s patients, who underwent 14 sessions of Brainsway Deep TMS treatment over three weeks. Each treatment session included low-frequency stimulation (1 Hz) of the motor cortex (M1) for 15 minutes, immediately followed by high-frequency stimulation (10 Hz) of the lateral prefrontal cortex for an additional 15 minutes.

The researchers’ conclusion is that the Deep TMS system with the unique coil that was developed for Parkinson’s disease is safe and effective for use as an add-on treatment for Parkinson’s patients. Additionally, the researchers concluded that Deep TMS can affect a wider range of symptoms than those previously reported in professional literature regarding the impact of treatment, based on standard TMS coils that generate only superficial stimulation (manufactured by a competing provider).

A randomized controlled feasibility and safety study of deep transcranial magnetic stimulation

Levkovitz, Y., Roth, Y., Harel, E. V., Braw, Y., Sheer, A., & Zangen, A. (2007). Clinical Neurophysiology, 118(12), 2730-2744.

This study examined possible effects of different Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coils and different stimulation parameters on healthy individuals. Several parameters relating to health, cognitive and emotional issues were checked .Results were also compared to a standard coil (figure 8) and to a sham coil. This study demonstrated that brain stimulation using the H-coil is feasible, safe and without adverse consequences.

Repetitive deep transcranial magnetic stimulation improves verbal fluency and written language in a patient with primary progressive aphasia-logopenic variant (LPPA)

Trebbastoni, A., Raccah, R., de Lena, C., Zangen, A., & Inghilleri, M. (2013). Brain stimulation, 6(4), 545-553.

This case report examines the effect of Brainsway Deep TMS (Transcranial Magnetic Stimulation) in a patient that had a language disorder involving changes in the ability to speak, read, write and understand what others are saying. The patient underwent four 20-minute stimulation cycles, including two real sessions and two sham sessions, over five consecutive days. In this patient, both the ability to speak and to write were significantly enhanced following one week of deep brain stimulation, but not following sham stimulation.

Safety and Efficacy Trial in Healthy Volunteers

National Institutes of Health (NIH), Bethesda, Maryland, USA

18 April, 2005

The first clinical study, Zangen et al. (2005), performed at the National Institute of Health (NIH) tested the efficacy and safety aspects of the H-coil on healthy volunteers.

The H-coil was compared to a regular figure-8 coil in 6 healthy volunteers by measuring thresholds for activation of the abductor pollicis brevis (APB) representation in the motor cortex as a function of distance from each of the coils. The findings of this study indicated that the rate of decrease in the coil intensity as a function of distance is markedly slower for the H-coil.

Safety and Feasibility Study in Treatment Resistant Major Depression

Shalvata Medical Health Center, Hod-Hasharon, Israel

14 February, 2008

This study evaluated the safety and feasibility of H- coil rTMS in the treatment of patients suffering from treatment-resistant MDD at the Shalvata Mental Health Center, Tel Aviv University, Israel. The study begun in 2006 and was completed in the beginning of 2008.

A Safety and Tolerability Study – Cognitive Effects in Healthy Volunteers

Shalvata Medical Health Center, Hod-Hasharon, Israel

1 January, 2006

A second safety study was conducted in Shalvata Mental-Health Center, Hod HaSharon, Israel in 2005 (Zangen et al., 2006).

The study assessed any possible health risks, as well as cognitive and emotional transient effects of the novel design of Brainsway® Deep TMS H-Coils.

Comparing treatments conducted with H1-coil, H2-coil, Standard figure-8 coil (Quadstim; manufactured by MagStim) and Sham coil. The treatment groups (H1-coil TMS, H2-coil TMS, figure-8 coil TMS & sham TMS) did not differ in age, years of education and sex.

Schizophrenia Negative Symptoms – Double-Blind Placebo Control Safety and Feasibility Study

Shalvata Mental Health Center, Hod Hasharon, Israel

9 March, 2009

A double-blind placebo-controlled clinical trial utilizing the Brainsway®’s Deep TMS device for the treatment of negative symptoms in 45 patients with schizophrenia has begun at the Shalvata Mental Health Center.

The trial began on March 2009, and is expected to be carried out over the course of 7 weeks in respect of each subject.

This trial is expected to serve as the basis for a broad multi-center trial.

Shimizu et al. Efficacy of deep rTMS for neuropathic pain in the lower limb: a randomized, double-blind crossover trial of an H-coil and figure-8 coil

A recent study performed in Japan compared the safety and efficacy of a Brainsway deep TMS H-coil, a standard figure-8 TMS coil and a sham coil (placebo) for the treatment of 18 patients suffering from neuropathic pain. All patients received all three types of treatment in a crossover design. It was found that only the deep TMS H-coil induced significant pain improvements, while the results of the figure-8 were not significantly different than the sham. The treatment was well tolerated and no serious adverse events were reported.

Smoking Cessation in Chronic Obstructive Pulmonary Disease – Double-Blind Placebo Control Safety and Feasibility Study

Be'er Ya'akov Mental Health Center, Israel

1 July, 2009

A clinical trial in Chronic Obstructive Pulmonary Disease Patients with an Addiction to Smoking, has begun at the Mental Health Center in Be’er Ya’akov, Israel.

The study aim is to assess the efficacy of Brainsway® Deep TMS device in inducing smoking cessation in chronic obstructive pulmonary disease patients. Between 90 and 120 patients are expected to participate in the trial. The trial will be a blinded placebo-controlled study.

Three-Dimensional Distribution of the Electric Field Induced in the Brain by Transcranial Magnetic Stimulation Using Figure-8 and Deep H-Coils

Roth, Y., Amir, A., Levkovitz, Y., & Zangen, A. (2007). Journal of Clinical Neurophysiology, 24(1), 31-38.

This study compares the penetration depths of two different Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coils and a standard coil (Figure 8 coil). In the study, electrical fields of H-coils and of a Figure 8 coil were measured using a head model. This study demonstrates that the H-coil is able to reach significantly deeper brain areas than those reached by the figure-of-8 coil. Also, it was shown that the H-coils allow for stimulation of several brain regions at the same time.

Transcranial magnetic brain stimulation modulates blepharospasm: a randomized controlled study.

Kranz, G., Shamim, E. A., Lin, P. T., Kranz, G. S., & Hallett, M. (2010). Neurology, 75(16), 1465-1471.

This study examined the effect of both the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil and circular-coil stimulation on patients suffering from abnormal blinking or spasms of the eyelids. In the study, patients underwent a 15-minute session of repetitive transcranial magnetic stimulation over the ACC. In this study it was demonstrated that although both type of coils were effective compare to a sham coil, and significantly alleviate symptoms, acute brain stimulation using the H-coil required a significantly lower stimulation intensity.

Transcranial magnetic stimulation of deep brain regions: evidence for efficacy of the H-coil.

Zangen, A., Roth, Y., Voller, B., & Hallett, M. (2005). Clinical neurophysiology, 116(4), 775-779

This study compares the penetration depths of the Brainsway® Deep TMS (Transcranial Magnetic Stimulation) H-coil to a standard coil (figure 8) in healthy individuals. The study tested the efficacy, and some issues related to safety, of the H-coil, on healthy volunteers. In this study it was demonstrated that the H-coil is able to reach significantly deeper brain areas than those reached by the figure-of-8 coil. Moreover, the stimulation is achieved without increasing the intensity to extreme levels.

Transcranial Magnetic Stimulation of Deep Brain Regions:Principles and Methods.

Roth, Y., Padberg, F., & Zangen, A. (2007). In “Transcranial Brain Stimulation for Treatment of Psychiatric Disorders” (Vol. 23).

This book chapter describes the biological and physical components that participate in the effects of Brainsway®’s Deep TMS (Transcranial Magnetic Stimulation) H-Coil for brain stimulation.

BrainsWay-D patients brochure