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NCT05608525
Upper Limb tDCS in Chronic Stroke Patients (NOURISH)
Conditions: Stroke
Sex: All
Ages: 21 Years – 80 Years
Phase: NA
Enrollment: 51
Sponsor: National University Hospital, Singapore
Location: Singapore
Summary
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.51 subjects will be recruited from National University Hospital (NUH) and be randomized to receive one of the followings:Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days.
Group 1 and Group 2 will receive tDCS for 20 minutes during each session, while Group 3 only receives the current stimulation for 20 seconds.
GRASP will be performed daily together with tDCS, either concurrently with or immediately after tDCS stimulation.The outcome measures will be measured at baseline, after intervention and 1 month after intervention, including:TMS measurement of corticospinal excitability;functional MRI scan;High density EEG (HD-EEG) evaluation;Clinical measures on upper limb motor function;Cognitive tests.
Eligibility Criteria
Inclusion Criteria:Age 21-80 years old;First ever stroke, 6 months to 2 years after stroke onset;ARAT≤42Exclusion Criteria:Pregnancy;Any metal implants inside the body that are contraindications of MRI scan;cardiac pacemakers;History of epilepsy;Sensorimotor disturbance due to other causes other than stroke;Claustrophobia;Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;Major depression and a history of psychotic disorders;Terminal diagnosis with life expectancy <=1 year.
Any metal implants inside the body that are contraindications of MRI scan;3. cardiac pacemakers; 4. History of epilepsy; 5. Sensorimotor disturbance due to other causes other than stroke; 6. Claustrophobia; 7. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina; 8. Major depression and a history of psychotic disorders; 9. Terminal diagnosis with life expectancy <=1 year.
Source: ClinicalTrials.gov (NCT05608525). StuddyBuddy aggregates publicly available trial information.