Multiple sclerosis (MS) 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, the 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Repetitive deep transcranial magnetic stimulation of prefrontal cortex or motor cortex or sham stimulation
Charite University Berlin (NeuroCure Clinical Research Center NCRC)
Berlin, Germany
Safety
examination by physician, assessement of adverse events
Time frame: 3x/week during treatment phase
Fatigue
Assessment of Fatigue via Fatigue Severity Scale FSS
Time frame: 3x/week during treatment period
Depressivity
Assessment of Depressivity via Beck Depression Inventory BDI
Time frame: 3x/week during treatment period
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