Significant improvement was observed in Parkinsonian patients, chronic migraineurs, patients with chronic lower-limb motor deficits and speech-impaired stroke victims
Further to Brainsway®'s (TASE:BRIN) announcement regarding the association between Brainsway and Advanced Technologies Innovation Distribution SRL (“ATID”) for the marketing and sales promotion of Brainsway's Deep TMS devices in Italy, in the context of which ATID has been conducting - among its other activities - clinical trials in the San Raffaele medical center in Milan, Italy, the Company is pleased to announce the following clinical trial results:
1. Clinical trial to evaluate the safety and efficacy of a specialized Deep TMS therapy for Parkinson's disease patients.
The trial was carried out in two phases. The first was a double-blind placebo-controlled phase. The data from this phase are still being analyzed. The following are the final results of the second, open-label phase of the trial, in which all patients received REAL Deep TMS treatment.
The trial included 27 Parkinsonian patients who received 12 high-frequency Deep TMS treatment sessions over the course of 30 days.
Analysis of patients' scores on the motor section of the Unified Parkinson's Disease Rating Scale (a commonly used scale for rating the severity of Parkinson's disease symptoms) revealed a significant improvement in severity of motor symptoms compared to the patients' pre-treatment (baseline) levels. Furthermore, significant improvement in tremor and rigidity subscores was already evident after the first treatment. The foot-tapping and hand-tapping subscores, which are commonly used to assess motor function, also improved following treatment.
No side effects were reported. These results demonstrate that magnetic stimulation of prefrontal and motor areas using Brainsway's Deep TMS device, with stimulation parameters as in the trial, is safe and effective for the treatment of Parkinsonian patients.
2. Clinical trial to evaluate the safety and efficacy of a specialized Deep TMS therapy for chronic migraine patients.
22 chronic migraineurs received 18 high-frequency Deep TMS treatment sessions over the course of six weeks. Treatment effects were assessed on weeks 4, 8, 12 and 24 after the beginning of treatment. The interim results demonstrate that 10 patients experienced a greater than 50% improvement in clinical scores in the following domains: migraine attack frequency, migraine intensity, level of medication use, and daily function. 7 patients exhibited partial improvement, i.e. between 20% and 40% improvement in scores in the abovementioned domains. No improvement was noted in the remaining 5 patients. No side effects were reported by any of the patients.
These results indicate that magnetic stimulation of prefrontal areas using Brainsway's Deep TMS device is safe and effective for the treatment of drug-resistant chronic migraineurs.
3. Clinical trial to evaluate the safety and efficacy of a specialized Deep TMS therapy for patients with chronic lower-limb motor deficits following a stroke.
The trial included 11 patients in the late stages of rehabilitation from a stroke (6 months to two years after their strokes). Each patient underwent 11 treatment sessions over the course of three weeks, using either high-frequency REAL stimulation, or SHAM-stimulation. After a 4-week break in treatment, the patients were administered the complementary treatment series (i.e., patients who had previously received REAL stimulation were administered SHAM stimulation, and vice versa).
Analysis of the interim results from this trial suggests that only REAL magnetic stimulation produced an improvement in patient scores on the 6-Minute Walk Test and on the FMLL scale for the assessment of lower-limb function (compared to baseline scores). The treatment effect was maintained, and remained statistically significant even four weeks after the end of treatment. No side effects were reported for this trial.
These results suggest that treatment using Brainsway's Deep TMS device is safe and effective for the treatment of lower-limb motor deficits in stroke patients in late-stage rehabilitation.
4. Clinical trial to evaluate the short-term effects of a specialized Deep TMS therapy for aphasic stroke patients.
The trial included 5 patients, each of whom was given three single session treatments at a random order: high-frequency treatment, low-frequency treatment and SHAM-treatment. The immediate effects of a single session of each of these treatments on the patients were assessed by standard neuropsychiatric tools administered before and after each treatment.
An analysis of the interim results indicates that only high-frequency stimulation was able to produce statistically significant (p=0.042) improvement in patients' scores, as compared to their pre-treatment scores and the low-frequency treatment. No side effects were observed.
The results suggest that high-frequency Deep TMS treatment over the language areas of the brain may have beneficial long-term effects in aphasic patients.
Ronen Segal, CTO of Brainsway, said ,"The conclusive results obtained in the clinical trials conducted at the San Raffaele Hospital, which is a one of the world's leading brain research centers, provide strong proof of the ability of Deep TMS technology to successfully treat even the most severe neurological disorders, such as Parkinson's disease and stroke. These are landmark results, which bring us a step closer to international recognition of the clinical potential of Brainsway's technology."
Amit Ginou, Director of Clinical Trials at Brainsway, commented, "These results, which will be presented at the next annual meeting of the American Academy of Neurology, are very promising and bring hope to many patients around the world."