JERUSALEM – November 8, 2015 – Brainsway® Ltd (TASE:BRIN), the leader in advanced noninvasive treatments for brain disorders, announced the final results of a study held at the Andrés Bello University in Santiago, Chile, in which Brainsway's Deep TMS coil developed for treating Parkinson's disease was found to be safe and effective as an add-on treatment for Parkinson's disease patients.
The study, conducted by Prof. Jimmy Satberg and his colleagues, 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 treatment's effect on the patients was tested using standard scales for rating the severity of Parkinson's disease symptoms before and after the 3 weeks of treatments, and in a follow up evaluation meeting that took place one month after the last treatment session.
The study found that in the period after the treatment – both immediately after it and in the follow-up session - there was a statistically significant, clear decline in a wide range of motor symptoms (such as walking pace, amount of falls, and stability) and non-motor symptoms (such as Parkinson's-associated depression). Furthermore, the treatment did not cause severe side effects or unusual discomfort.
The key innovative finding of the study relates to the duration of the patients' response to the medication that was administered in addition to Deep TMS. The study shows that the daily response time to medication increased by 73% on average (from 4.4 to 7.6 hours per day). This includes patients who did not respond to medication at all at the treatment start; in these patients, the response time increased from 0 to 6.3 hours on average per day. Furthermore, in some cases, the medication dose was reduced at the conclusion of the treatments (to ease the side effects of these medications), and no increase in the severity of the symptoms was observed after the reduction in medication doses.
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).
The information in this report is a description of the final results of a preliminary experiment which included a relatively small number of participants. These results do not necessarily point to the effectiveness of Deep TMS for treating Parkinson's disease, and there is no certainly of this, and it is subject to successful completion of additional studies; This could take a long while, and there is no certainty regarding the duration of time required to complete the licensing procedure for the company's device for treating the above mentioned phenomena, and regarding the success of this procedure, and the costs entailed.