Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere (UH) transiently improves motor function in patients in the chronic phase after stroke. The goal of this study is to investigate effects on motor recovery of low-frequency rTMS of the UH, administered in the subacute phase after stroke.
Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after stroke. Even mild impairments of the upper limb negatively impact disability and quality of life in these patients significantly contributes to disability. Therapeutic alternatives for hand motor rehabilitation are deeply needed. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the paretic hand Both strategies, as well as the combination of both, have yielded encouraging results when applied in proof-of-principle, single-session studies to patients with mild hand motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies included patients less than six months after stroke, and effects of LF-rTMS of the unaffected hemisphere in patients with severe motor impairment in the subacute phase have not been yet reported. The investigators opted for a novel approach to enhance hand motor recovery, by examining feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor deficits, will have minimal adverse events and will enhance effects of customary rehabilitation on hand motor performance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Laboratório de Neuroestimulação, HC/FMUSP
São Paulo, São Paulo, Brazil
Motor function of the paretic hand evaluated with the Jebsen-Taylor test
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of patients able to comply with the protocol
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Force of the paretic hand
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Fugl-Meyer evaluation of motor performance (upper limb)
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Disability evaluated with the modified Rankin scale
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Functional Independence Measure
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Neurological impairment evaluated with the NIH Stroke Scale
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Measures of corticomotor excitability evaluated with transcranial magnetic stimulation
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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