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

Vincenzo Di Lazzaro, Fabio Pilato, Paolo Profice, Federico Ranieri, Gabriella Musumeci, Lucia Florio, Ettore Beghi, Giovanni Frisullo, Fioravante Capone, Mario Sabatelli, Pietro A. Tonali, Michele Dileone

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)18-21
Number of pages4
JournalNeuroscience Letters
Volume464
Issue number1
DOIs
Publication statusPublished - Oct 16 2009

Keywords

  • ALS
  • Glutamate
  • TMS

ASJC Scopus subject areas

  • Neuroscience(all)

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