Status:
COMPLETED
Combined Brain and Peripheral Nerve Stimulation for Stroke
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Fundação Faculdade de Medicina
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilita...
Detailed Description
The goal of this study is to compare the effects of FES in close association with either transcranial direct current stimulation (tDCS) alone, peripheral nerve stimulation (PNS)alone, tDCS + PNS or sh...
Eligibility Criteria
Inclusion
- Age, 18 years or older;
- First-ever, ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function;
- Ability to provide written Informed Consent (patient or legal representative);
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion
- Lack of ability to voluntarily activate any active range of wrist extension;
- Anesthesia of the paretic hand;
- Stroke lesions affecting entirely the hand knob area of the motor cortex120;
- Stroke lesions affecting the cerebellum or the brain stem;
- Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of \>3 on the Modified Ashworth Spasticity Scale;
- Active joint deformity;
- Uncontrolled medical problems such as end-stage cancer or renal disease;
- Pregnancy;
- Seizures;
- Pacemakers;
- Other neurological disorders such as Parkinson's disease;
- Psychiatric illness including severe depression;
- Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent. A score in the Minimental State Examination lower than 23/30 points will be used for patients with higher than 1 year of education, and a score lower than 19/30 will be used for patients with 1 year of education or less.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01907737
Start Date
July 1 2013
End Date
July 1 2016
Last Update
July 19 2019
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina
São Paulo, São Paulo, Brazil, 05403000