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(Stroke. 2006;37:2115.)
© 2006 American Heart Association, Inc.

Original Contributions

A Sham-Controlled Trial of a 5-Day Course of Repetitive Transcranial Magnetic Stimulation of the Unaffected Hemisphere in Stroke Patients

Felipe Fregni, MD, PhD; Paulo S. Boggio, MSc; Angela C. Valle, PhD; Renata R. Rocha; Julia Duarte; Merari J.L. Ferreira; Tim Wagner, MSc; Shirley Fecteau, PhD; Sergio P. Rigonatti, MD, PhD; Marcelo Riberto, MD; Steven D. Freedman, MD, PhD Alvaro Pascual-Leone, MD, PhD

From the Harvard Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (F.F., T.W., S.F., S.D.F., A.P.-L.); the Departments of Experimental Psychology (P.S.B.), Psychiatry (S.P.R.), and Pathology (A.C.V.), University of Sao Paulo, Sao Paulo, Brazil; Mackenzie University, Sao Paulo, Brazil (P.S.B., J.D., R.R.R., M.J.L.F.); the Division of Physical Medicine and Rehabilitation, University of Sao Paulo, Sao Paulo, Brazil (M.R.); and the Institut Guttmann (A.P.-L.), Universidad Autonoma de Barcelona, Spain.

Correspondence to Felipe Fregni, MD, PhD; Harvard Center for Non-invasive Brain Stimulation, 330 Brookline Ave, KS 452, Boston, MA 02215. E-mail ffregni{at}bidmc.harvard.edu

Background and Purpose— It has been recently shown that a single session of repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere can improve motor function in stroke patients; however, this improvement is short-lasting. We therefore conducted a randomized, sham-controlled, phase II trial to evaluate whether five sessions of low-frequency rTMS can increase the magnitude and duration of these effects and whether this approach is safe.

Methods— Fifteen patients with chronic stroke were randomized to receive active or sham rTMS of the unaffected hemisphere. A blinded rater assessed motor function and corticospinal excitability at baseline, during and after 2 weeks of treatment. Safety was assessed using a neuropsychologic battery and electroencephalogram.

Results— Active rTMS resulted in a significant improvement of the motor function performance in the affected hand that lasted for 2 weeks. These effects were not observed in the sham rTMS group (affected and unaffected hand) and in the unaffected hand in the active rTMS group. Corticospinal excitability decreased in the stimulated, unaffected hemisphere and increased in the affected hemisphere. There was a significant correlation between motor function improvement and corticospinal excitability change in the affected hemisphere. Cognitive performance and electroencephalogram were not changed significantly throughout the trial in both groups of treatment.

Conclusions— These results support and extend the findings of previous studies on rTMS in stroke patients because five consecutive sessions of rTMS increased the magnitude and duration of the motor effects. Furthermore, this increased dose of rTMS is not associated with cognitive adverse effects and/or epileptogenic activity.

Key Words: cerebrovascular accident • electrical stimulation of the brain • recovery of function • stroke

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