Status:
UNKNOWN
Robotic Therapy and Brain Stimulation in the Early Phase After Stroke
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential in...
Detailed Description
The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor perfo...
Eligibility Criteria
Inclusion
- Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.
- Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.
- Ability to provide written informed consent.
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion
- Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of \> 3 in the Modified Ashworth Spasticity Scale.
- No active shoulder and elbow movements
- Uncontrolled medical problems such as end-stage cancer or renal disease
- Pregnancy
- Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)
- Other neurological disorders such as Parkinson's disease
- Psychiatric illness
- Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
- Hemineglect
- Cerebellar lesions or on cerebellar pathways
- Contact precautions
Key Trial Info
Start Date :
August 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03230695
Start Date
August 3 2017
End Date
July 1 2025
Last Update
October 28 2022
Active Locations (1)
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1
Suzana Bleckmann Reis
São Paulo, Brazil, 05403900