title: No effects of 20 Hz-rTMS of the primary motor cortex in vegetative state: A randomised, sham-controlled study.
abstract: We assessed the effects of a non-invasive neuromodulatory intervention with repetitive transcranial magnetic stimulation (rTMS) of the motor cortex in patients with vegetative state (VS) by a randomised, sham-controlled study with a cross-over design. Eleven patients classified as being in VS (9 post-anoxic, 2 post-traumatic, time elapsed from the injury 9-85 months) were included in the study. Real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) for 5 consecutive days. Primary outcome measures were changes in the JFK Coma Recovery Scale-Revised (CRS-R) scale total score and Clinical Global Impression Improvement (CGI-I) scale. Additional measures were EEG changes and impression of the patients' relatives using the CGI-I scale. Evaluations were blindly performed at baseline, after the first day of treatment, immediately after the end of the 5-days treatment, 1 week and 1 month later. Slight changes observed in the CRS-R and CGI-I scores did not significantly differ between real or sham stimulation conditions. EEG was not significantly changed on average, although spots of brain reactivity were occasionally found underneath the stimulation point. Findings did not provide evidence of therapeutic effect of 20 Hz rTMS of the M1 in chronic VS, at least with conventional coils and current safety parameters. Therefore, they might be useful to better allocate human and financial resources in future trials.
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy. Electronic address: cincotta@unifi.it.
authors: Massimo
authors: M
authors: Cincotta
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy; Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.
authors: Fabio
authors: F
authors: Giovannelli
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy.
authors: Roberta
authors: R
authors: Chiaramonti
authors: Department of Neuroscience, Brain Investigation & Neuromodulation Lab (Si-BIN Lab), UOC Neurology and Clinical Neurophysiology, Azienda Ospedaliera-Universitaria Senese, Siena, Italy.
authors: Giovanni
authors: G
authors: Bianco
authors: Department of Neuroscience, Brain Investigation & Neuromodulation Lab (Si-BIN Lab), UOC Neurology and Clinical Neurophysiology, Azienda Ospedaliera-Universitaria Senese, Siena, Italy.
authors: Marco
authors: M
authors: Godone
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy.
authors: Donato
authors: D
authors: Battista
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy.
authors: Consuelo
authors: C
authors: Cardinali
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy.
authors: Alessandra
authors: A
authors: Borgheresi
authors: Casa di Cura Villa delle Terme, Florence, Italy.
authors: Antonella
authors: A
authors: Sighinolfi
authors: Casa di Cura Villa delle Terme, Florence, Italy.
authors: Anna Maria
authors: AM
authors: D'Avanzo
authors: Casa di Cura Villa delle Terme, Florence, Italy.
authors: Marco
authors: M
authors: Breschi
authors: Casa di Cura Villa delle Terme, Florence, Italy.
authors: Ylli
authors: Y
authors: Dine
authors: Casa di Cura Villa delle Terme, Florence, Italy.
authors: Mario
authors: M
authors: Lino
authors: Unit of Neurology, Azienda Sanitaria di Firenze, Florence, Italy.
authors: Gaetano
authors: G
authors: Zaccara
authors: Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.
authors: Maria Pia
authors: MP
authors: Viggiano
authors: Department of Neuroscience, Brain Investigation & Neuromodulation Lab (Si-BIN Lab), UOC Neurology and Clinical Neurophysiology, Azienda Ospedaliera-Universitaria Senese, Siena, Italy.
authors: Simone
authors: S
authors: Rossi
mesh_terms: D000328:Adult; D000368:Aged; D001303:Auditory Cortex; D003128:Coma / Q000628:therapy; D018592:Cross-Over Studies; D004569:Electroencephalography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009044:Motor Cortex / Q000503:physiopathology*; D018458:Persistent Vegetative State / Q000503:physiopathology / Q000628:therapy*; D020127:Recovery of Function; D050781:Transcranial Magnetic Stimulation / Q000379:methods*; D016896:Treatment Outcome; D014793:Visual Cortex
keywords: Disorders of consciousness; Transcranial magnetic stimulation; Vegetative state; rTMS