Status:
RECRUITING
Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Cerebrovascular Accident
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief Summary
The primary aim of this project will be to determine the effects of the tRNS-augmented unilateral and bilateral MT, and their effects relative to the control interventions (sham tRNS with unilateral o...
Detailed Description
Developing effective rehabilitation interventions to maximize functional recovery remains to be a major challenge for stroke rehabilitation. Transcranial random noise stimulation (tRNS) has emerged as...
Eligibility Criteria
Inclusion
- ≥ 3 months onset from a first-ever unilateral stroke;
- an initial FMA scores between 18 to 56, indicating moderate to mild upper extremity motor impairment (Thielman, Kaminski, \& Gentile, 2008);
- age between 35 to 85;
- no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist and fingers);
- ability to follow instructions and perform tasks (Mini Mental State Examination scores ≥24);
- no participation in any neurorehabilitation experiments or drug clinical trials and
- willing to provide written informed consent.
Exclusion
- contradiction to tRNS including a history of epilepsy, pregnant, having pacemakers and metallic implants in the neck and heads (Rossi, Hallett, Rossini, Pascual-Leone, \& Safety of, 2009);
- History of drug or alcohol abuse(Rossi et al., 2009);
- concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
- Botulinum toxin injections 3 months before enrollment
- have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure or are not suitable for receiving tRNS by the physician's assessments.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05238272
Start Date
March 1 2022
End Date
December 31 2026
Last Update
February 14 2022
Active Locations (1)
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1
Chang Gung Memotial Hospital
Taoyuan District, Taiwan, 333