Multiple Sclerosis – Double-Blind Placebo Control Safety and Feasibility Study

Charité University, Berlin, Germany; University Medical Center Hamburg-Eppendorf, Hamburg, Germany

21 March, 2010

A clinical trial of BrainsWay®’s Deep TMS for the treatment of multiple sclerosis patients (MS) has begun in two leading medical centers in Germany: the Charité Hospital – considered to be the leading university hospital in Berlin, and the University Medical Center Hamburg-Eppendorf, in Hamburg.

Multiple sclerosis is a chronic-inflammatory autoimmune central nervous system disorder and a leading cause of neurological disability in younger adults in Western countries. Besides “classic” neurological symptoms both depressivity and fatigue are among the most frequent symptoms in MS, affecting up to 90% of patients at onset or during the course of the disease. Neither are the psychological and immunological backgrounds of both well understood, nor are there numerous controlled therapeutic trials which would offer convincing treatment options for fatigue and depressivity in MS.

Transcranial magnetic stimulation (TMS) has been frequently used to investigate altered hemispheric and inter-hemispheric connectivity in MS. Recently, first therapeutic trials have been performed to address specific MS-related symptoms by TMS. Koch et al. demonstrated an improvement of hand dexterity following repetitive TMS, and Centonze and colleagues showed reduced spasticity following TMS.

Recently, a specific coil for the stimulation of deeper brain regions including the deep nuclei was developed, BrainsWay’s so-called H-coil. It successfully stimulates deeper (pre-frontal) brain regions. Stimulation with this coil has been shown to be safe and well tolerated in healthy volunteers, and in patients suffering from major depression.

The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex (PFC) of MS patients. The PFC is the region at which stimulation is aimed in previous depression studies as this brain region has been shown to play a relevant role in affective disorders. It is the primary aim of this study, to evaluate the safety and tolerability of deep TMS with the H-coil in MS patients with fatigue or depressivity.

The trial is expected to include a total of 36 patients at both medical centers, with an expected treatment duration of 16 weeks for each patient.

The efficacy of the treatment will be assessed using fatigue and depression rating scales, multiple sclerosis rating scales, analysis of blood levels of a neurotrophic factor called BDNF, and additional clinical evaluations.