TY - JOUR
T1 - Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue
AU - Gaede, Gunnar
AU - Tiede, Marina
AU - Lorenz, Ina
AU - Brandt, Alexander U.
AU - Pfueller, Caspar
AU - Dörr, Jan
AU - Bellmann-Strobl, Judith
AU - Piper, Sophie K.
AU - Roth, Yiftach
AU - Zangen, Abraham
AU - Schippling, Sven
AU - Paul, Friedemann
N1 - Funding Information:
From the 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. Funding information and disclosures are provided at the end of the article. Go to Neurology.org/nn for full disclosure forms. The Article Processing Charge was funded by the authors. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Publisher Copyright:
Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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. ClinicalTrials.gov 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.
AB - 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. ClinicalTrials.gov 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.
UR - http://www.scopus.com/inward/record.url?scp=85044283870&partnerID=8YFLogxK
U2 - 10.1212/NXI.0000000000000423
DO - 10.1212/NXI.0000000000000423
M3 - Article
C2 - 29259998
AN - SCOPUS:85044283870
SN - 2332-7812
VL - 5
JO - Neurology: Neuroimmunology and NeuroInflammation
JF - Neurology: Neuroimmunology and NeuroInflammation
IS - 1
M1 - e423
ER -