Brainsway is pleased to announce that it has received the final results of a clinical trial performed at the Hadassah Medical Center to explore the efficacy of Deep TMS in the treatment of post-traumatic stress disorder (PTSD). The principal investigator of the trial was Dr. Moshe Isserles. The final results are for 26 patients (out of the 30 who enrolled in the trial), each of whom received at least 8 treatment sessions (the minimum amount required for treatment).
Final analysis of these results has revealed that Deep TMS therapy in conjunction with brief exposure to trauma cues (reminders of a traumatic event, transmitted to the patients through earphones), is safe and effective for the treatment of PTSD.
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.
Shalvata Mental Health Center, Hod Hasharon, Israel
28 June, 2010
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.
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.
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.
Hadassah Ein-Kerem Medical Center, Jerusalem, and Be'er Ya'akov Mental Health Center, Israel
6 August, 2009
A clinical trial of studying the feasibility of using the Deep TMS H System in augmentation of antidepressant drugs, for the treatment of resistant depression. The trial included 56 patients. According to the findings of the Final Report, the treatment using the Deep TMS device in conjunction with antidepressant drug therapy was found to be safe and effective.
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
According to the findings of the Final Report, all subjects (20) took the treatment well, and 70% of the subjects responded to the treatment (a vast majority of same with significant improvement) as compared with previous treatment with anti-depressants that were given to the subjects.
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.
First results of the study show improvement in the negative schizophrenic symptoms of the patients.
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 2005 (Zangen et al., 2006). The study assessed any possible health risks, as well as cognitive and emotional transient effects of the novel design Deep TMS H-Coils.
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.
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