Deep rTMS with H-Coil Associated with Rehabilitation Enhances Improvement of Walking Abilities in Patients with Progressive Multiple Sclerosis: Randomized, Controlled, Double Blind Study (S49.007)

Abstract

Objective: To investigate whether repeated sessions of transcranial repetitive magnetic stimulation (rTMS) with H-coil could enhance the benefit of rehabilitation on walking abilities in patients with spasticity associated with multiple sclerosis (MS).

Background Impaired walking has a strong impact on disability associated with MS and its treatments options are limited. Preliminary findings showed that repeated sessions of focal repetitive transcranial stimulation improved spasticity associated with MS but no data are available on the impact on walking ability. Recently, the development of H-coils has been proved to allow reaching deeper brain regions as compared with focal stimulation.

Design/Methods: Twenty-three progressive MS patients with lower limb spasticity, undergoing inpatients rehabilitation, were randomized to receive real (11 pts) or sham (11 pts; one patient refused to participate after randomization) 10-min sessions of high-frequency rTMS for 3 weeks following their rehabilitation sessions. Primary outcome was percent change at the 10-meter walk test. Secondary outcomes were: walking-endurance (6-min walking test), Modified Ashworth Scale (MAS) and Visual Analogue Scale (VAS) for spasticity, Fatigue Severity Scale (FSS), EDSS, PASAT and Nine-Hole Peg Test (9HPT).

Results: At the end of treatment, both groups showed improvement in all outcome parameters, although significant improvement in walking tests (10-mt-WT and 6-min-WT) was significant in the real rTMS group only. The latter group, when compared with the sham group, had significantly better improvement of the primary outcome (10-mt-WT; p<0.05) and of 6-min-WT (p=0.002) and MAS score (p=0.037). No serious adverse effects were reported and no patient discontinued the study due to adverse effects.

Conclusions: These findings demonstrate that deep brain stimulation with H-Coil increases the effects of rehabilitation in improving walking ability, in terms of both speed and endurance. The treatment is safe and feasible. These encouraging results need to be validated with phase-3 studies.

Disclosure: Dr. Leocani has nothing to disclose. Dr. Nuara has nothing to disclose. Dr. Formenti has nothing to disclose. Dr. Rossi has nothing to disclose. Dr. Zangen has nothing to disclose. Dr. Comola has nothing to disclose. Dr. Comi has received personal compensation for activities with Novartis, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Merck Serono, Bayer Schering, and Biogen Dompe.