Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
NCT ID: NCT01333579
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2008-02-29
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS
1Hz active rTMS delivered to the unaffected hemisphere
Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Placebo rTMS
1Hz placebo rTMS delivered to the vertex
Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Interventions
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Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Eligibility Criteria
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Inclusion Criteria
* Age, 18-80 years
Exclusion Criteria
* Pregnancy
* Implantable medication pump
* Intracranial hypertension
* History of seizures
* Metal in the head
* Decompressive surgery
* Other neurological diseases
* Shoulder pain
* Joint deformity in the paretic upper limb
* Severe chronic disease such as end-stage cancer or end-stage renal failure
* Inability to provide informed consent due to severe language or cognitive impairment
18 Years
80 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Adriana Bastos Conforto
Professor and Neurologist, Neurostimulation Laboratory
Principal Investigators
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Adriana Conforto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HC/FMUSP/Fundação Faculdade de Medicina
Locations
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Laboratório de Neuroestimulação, HC/FMUSP
São Paulo, São Paulo, Brazil
Countries
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References
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Anjos SM, Cohen LG, Sterr A, de Andrade KN, Conforto AB. Translational neurorehabilitation research in the third world: what barriers to trial participation can teach us. Stroke. 2014 May;45(5):1495-7. doi: 10.1161/STROKEAHA.113.003572. Epub 2014 Mar 18.
Other Identifiers
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NCT2006/55504-0
Identifier Type: -
Identifier Source: org_study_id