NCT05238272 Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke
| NCT ID | NCT05238272 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Cerebrovascular Accident |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2022-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 or bilateral MT) on restoring health outcomes including motor function, daily function, quality of life and self-efficacy, and motor control strategy as well as brain activities (electroencephalography, EEG) in stroke patients.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 3 months onset from a first-ever unilateral stroke; 2. an initial FMA scores between 18 to 56, indicating moderate to mild upper extremity motor impairment (Thielman, Kaminski, \& Gentile, 2008); 3. age between 35 to 85; 4. no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist and fingers); 5. ability to follow instructions and perform tasks (Mini Mental State Examination scores ≥24); 6. no participation in any neurorehabilitation experiments or drug clinical trials and 7. willing to provide written informed consent. Exclusion Criteria: 1. 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); 2. History of drug or alcohol abuse(Rossi et al., 2009); 3. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema); 4. Botulinum toxin injections 3 months before enrollment 5. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05238272 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 85 Years, studying Cerebrovascular Accident. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05238272 currently recruiting?
Yes, NCT05238272 is actively recruiting participants. Contact the research team at cywu@mail.cgu.edu.tw for enrollment information.
Where is the NCT05238272 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT05238272 clinical trial?
NCT05238272 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 128 participants.