Brainsway has obtained Deep transcranial magnetic stimulation (TMS) device interim multiple sclerosis (MS) trial results.
The double-blinded trial, which enrolled 26 patients, was designed to evaluate the safety and efficacy of the TMS device at the Charite Hospital in Berlin and at the University Medical Center Hamburg-Eppendorf in Hamburg.
The patients were divided into a sham-stimulation control group, a treatment group which received high-frequency (18 Hz) left prefrontal stimulation, and other group which received low-frequency (5 Hz) motor cortex stimulation.
Subjects’ fatigue levels were evaluated using Fatigue Severity Scale (FSS), the Modified Fatigue Impact Scale (MFIS) and the Visual Analogue Scale (VAS).
The effects on subjects’ depression levels were evaluated using the Hamilton Rating Scale for Depression, the Beck Depression Inventory (BDI) and the Positive and Negative Affect Scale (PANAS).
The results showed that the left prefrontal stimulation group patients were observed with non-significant improvement in VAS scores and demonstrated either no improvement or only non-significant improvement on fatigue rating scales.
Both treatment groups have demostrated non-significant improvement in MFIS scores.
The motor cortex stimulation group patients were observed with significant improvement on the BDI and the PANAS, while the other groups’ scores were not observed with any improvements.
Study principle investigator said these results indicate that Deep TMS therapy with Brainsway’s device is safe and effective for the treatment of MS patients, and that it may even alleviate these patients’ fatigue symptoms.
"The treatment’s effects on metabolic and neural activity have not yet been investigated, and will be addressed in future studies," the investigator said.