Motor cortex stimulation for ALS: a double blind placebo-controlled study.

Full Abstract

Preliminary data suggest that repetitive transcranial magnetic stimulation (rTMS) of the brain may produce a modest slowing of disease progression in amyotrophic lateral sclerosis (ALS). The present study was designed to test the hypothesis that rTMS given as continuous theta burst stimulation (cTBS), repeated monthly for one year, would affect ALS progression. We performed a double blind, placebo-controlled trial. Twenty patients with ALS were randomly allocated to blinded real or placebo stimulation. cTBS of the motor cortex was performed for five consecutive days every month for one year. Primary outcome was the rate of decline as evaluated with the revised ALS functional rating scale (ALSFRS-R). Treatment was well tolerated. There was no significant difference in the ALSFRS-R score deterioration between patients treated with real or placebo stimulation. ALSFRS-R mean scores declined from 32.0 (SD 7.1) at study entry to 23.1 (SD 6.3) at 12 months in patients receiving real cTBS and from 31.3 (SD 6.9) to 21.2 (SD 6.0) in those receiving placebo stimulation. Although cTBS proved a safe procedure, on the basis of the present findings a larger randomized confirmatory trial seems unjustified in ALS patients, at least in advanced stage of the disease.

Author information

Author/s: Di Lazzaro, Vincenzo (V); Pilato, Fabio (F); Profice, Paolo (P); Ranieri, Federico (F); Musumeci, Gabriella (G); Florio, Lucia (L); Beghi, Ettore (E); Frisullo, Giovanni (G); Capone, Fioravante (F); Sabatelli, Mario (M); Tonali, Pietro A (PA); Dileone, Michele (M);

Affiliation: Institute of Neurology, Università Cattolica, 00168 Rome, Italy. vdilazzaro(-atsign-)rm.unicatt.it

Journal and publication information

Publication Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Neuroscience letters (Neurosci Lett), published in Ireland. (Language: eng)

Reference: 2009-Oct; vol 464 (issue 1) : pp 18-21

Dates: Created 2009/08/31; Completed 2009/11/03;

PMID: 19682544, status: MEDLINE (last retrieval date: 11/3/2009, IMS Date: )

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