Motor cortex stimulation for ALS: a double blind placebo-controlled study.
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.
Di Lazzaro
Vincenzo
V
Institute of Neurology, Università Cattolica, 00168 Rome, Italy. vdilazzaro@rm.unicatt.it
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
D000328:Adult; D000368:Aged; D000690:Amyotrophic Lateral Sclerosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D019208:Brain-Derived Neurotrophic Factor / Q000096:biosynthesis / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009044:Motor Cortex / Q000503:physiopathology*; D010865:Pilot Projects; D050781:Transcranial Magnetic Stimulation
D019208:Brain-Derived Neurotrophic Factor