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Neurol Neuroimmunol Neuroinflamm. 2017 Dec 13;5(1):e423. doi: 10.1212/NXI.0000000000000423. eCollection 2018 Jan.

Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue.

Author information

1
NeuroCure Clinical Research Center (G.G., A.U.B., C.P., J.D., J.B.-S., S.K.P., F.P.), Center for Stroke Research Berlin (CSB) (S.K.P.), Experimental and Clinical Research Center (J.B.-S., F.P.), and Clinical and Experimental Multiple Sclerosis Research Center (F.P.), Department of Neurology, Charité-Universitätsmedizin Berlin, Germany; Institute of Neuroimmunology and Multiple Sclerosis (M.T., I.L., S.S.), University Medical Centre Hamburg-Eppendorf, Germany; Department of Life Sciences (Y.R., A.Z.), Ben-Gurion University, Beer-Sheva, Israel; and Max-Delbrück Center for Molecular Medicine (F.P.), Berlin, Germany. G.G. and C.P. are now with St. Joseph Krankenhaus-Berlin-Weissensee, Germany. S.S. is now with Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Switzerland.

Abstract

Objective:

To conduct a randomized, sham-controlled phase I/IIa study to evaluate the safety and preliminary efficacy of deep brain H-coil repetitive transcranial magnetic stimulation (rTMS) over the prefrontal cortex (PFC) and the primary motor cortex (MC) in patients with MS with fatigue or depression (NCT01106365).

Methods:

Thirty-three patients with MS were recruited to undergo 18 consecutive rTMS sessions over 6 weeks, followed by follow-up (FU) assessments over 6 weeks. Patients were randomized to receive high-frequency stimulation of the left PFC, MC, or sham stimulation. Primary end point was the safety of stimulation. Preliminary efficacy was assessed based on changes in Fatigue Severity Scale (FSS) and Beck Depression Inventory scores. Randomization allowed only analysis of preliminary efficacy for fatigue.

Results:

No serious adverse events were observed. Five patients terminated participation during treatment due to mild side effects. Treatment resulted in a significant median FSS decrease of 1.0 point (95%CI [0.45,1.65]), which was sustained during FU.

Conclusions:

H-coil rTMS is safe and well tolerated in patients with MS. The observed sustained reduction in fatigue after subthreshold MC stimulation warrants further investigation.

ClinicalTrialsgov identifier:

NCT01106365.

Classification of evidence:

This study provides Class III evidence that rTMS of the prefrontal or primary MC is not associated with serious adverse effects, although this study is underpowered to state this with any precision.

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