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. ...Read More
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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.
The study included 53 adult ADHD patients, who were randomly assigned to one of three treatment groups in a double-blind manner (treatment allocation was concealed from both investigator and patient). Each patient was randomized to receive 15 treatments over 3 weeks (5 daily treatments a week) of either Deep TMS using either a specialized coil developed by Brainsway for deep stimulation of the right frontal lobe (Brainsway’s proprietary H6-Coil), standard TMS using a figure-8 TMS coil which stimulates only the surface of the right frontal lobe, or sham TMS. The results are based on the 42 participants that concluded the treatment period, as 11 patients left the study early – 10 of them left due to reasons unrelated to the device or procedure, and one patient in the standard TMS treatment group left due to the occurrence of a seizure.
Treatment effects were assessed using standard ADHD rating scales, a computerized task for objective evaluation of attentional functioning, and electroencephalography (EEG) to record electrical activity in the patients’ brains.
The primary efficacy outcome measure was the change in scores on the Conner’s Adult ADHD Rating Scale (CAARS) self-report questionnaire. In the Deep TMS group, a significant average improvement of 8.25 points (p=0.0001) was observed in total CAARS scores compared with pre-treatment baseline values. However, in the sham TMS group, there was an insignificant change (p=0.33) of 1.86 points only. In the standard TMS group, the change was only 2.85 points (p=0.15). Similar results were observed on all ADHD symptom subscales.
The percentage of patients who responded to the treatment (who showed a reduction of 30% or more in the CAARS scale) was 33% in the Deep TMS group, 8% in the sham group, and 15% in the standard TMS group).
According to the Principal Investigators, the results of this study demonstrate that Deep TMS using Brainsway’s specialized ADHD H-Coil is safe, and may be used to effectively treat ADHD. The results of the study also 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.