99. Lack of behavioural effects of high-frequency rTMS in vegetative state: A randomised, double blind, sham-controlled, cross-over study
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In a patient with minimal conscious state has been reported an arousal with transient increase of meaningful behaviours and EEG changes after rTMS over the M1. This has raised interest in the scientific community but has also had disproportionate resonance in mass media and strong expectations among the patients¡¯ families. We evaluated the effect of high-frequency rTMS in vegetative state (VS) by a randomised, double blind, sham-controlled trial with a cross-over design. Eleven VS patients were included. Twenty-Hz rTMS or sham stimulation were applied to the left M1 for 5 consecutive days. Daily sessions consisted of 10-min stimulation at 60 % maximum stimulator output. Primary outcome measures were changes in the Coma Recovery Scale-Revised (CRS-R) total score and Clinical Global Impression (CGI) scale. Evaluations were performed at baseline, after the first day of treatment, immediately after the end of the treatment, and 1 week and 1 month later.

Slight changes observed in CRS-R and CGI did not significantly differ between real or sham stimulation conditions. In addition, no concordance was seen between CGI changes observed by clinician and patients¡¯ relatives.

Findings do not provide evidence of therapeutic effect of rTMS in VS, at least with conventional coils and current safety parameters.

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