Brainsway and Advanced Technologies Innovation Distribution (ATID) have reached an agreement for the marketing and sales promotion of Brainsway's deep transcranial magnetic stimulation (TMS) devices in Italy. ATID has been conducting, among its other activities, clinical trials in the San Raffaele medical centre in Milan, Italy. Brainsway has also revealed the following clinical trial results:
Clinical trial to evaluate the safety and efficacy of a specialised 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 of which are still being analysed. 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 Parkinson's disease (PD) 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 revealed a significant improvement in severity of motor symptoms compared to the patients' baseline levels. Furthermore, significant improvement in tremor and rigidity subscores was already evident after the first treatment. Foot-tapping and hand-tapping subscores, used to assess motor function, also improved following treatment.
No side effects were reported. These results demonstrated that magnetic stimulation of prefrontal and motor areas using the deep TMS device, with stimulation parameters as in the trial, is safe and effective for the treatment of PD patients.
Clinical trial to evaluate the safety and efficacy of a specialised deep TMS therapy for chronic migraine patients
A total of 22 chronic migraine patients received 18 high-frequency deep TMS treatment sessions over the course of six weeks. Treatment effects were assessed on weeks four, eight, 12 and 24 after the beginning of treatment. The interim results demonstrated that ten patients experienced a > 50 per cent improvement in clinical scores in the following domains: migraine attack frequency, migraine intensity, level of medication use and daily function. In total, seven patients exhibited partial improvement, between 20 and 40 per cent improvement in scores in the aforementioned domains. No improvement was noted in the remaining five patients. No side effects were reported by any of the patients.
These results indicate that magnetic stimulation of prefrontal areas using the deep TMS device is safe and effective for the treatment of drug-resistant chronic migraine patients.
Clinical trial to evaluate the safety and efficacy of a specialised 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, six 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 four-week break in treatment, the patients were administered the complementary treatment series; patients who had previously received real stimulation were administered sham stimulation, and vice versa.
Analysis of the interim results from this trial suggested that only real magnetic stimulation produced an improvement in patient scores on the six-minute walk test and on the FMLL scale for the assessment of lower-limb function, compared with 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.
Clinical trial to evaluate the short-term effects of a specialised deep TMS therapy for aphasic stroke patients
The trial included five patients, each of whom were 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 indicated that only high-frequency stimulation was able to produce statistically significant improvement (p=0.042) in patients' scores, as compared with their pre-treatment scores and the low-frequency treatment. No side effects were observed.