Using brain neurotechnology to enhance mirror therapy for stroke recovery
Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke
This study is testing if adding a brain stimulation technique to mirror therapy can help stroke patients recover better and improve their daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05238272 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effects of transcranial random noise stimulation (tRNS) combined with mirror therapy (MT) on stroke patients. The study will compare the effectiveness of unilateral and bilateral MT approaches augmented with tRNS against control interventions. By measuring health outcomes such as motor function, daily living activities, quality of life, and brain activity through EEG, the research seeks to identify the optimal combination of therapies for enhancing recovery. This innovative approach aims to leverage brain neurotechnology to improve rehabilitation outcomes for stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 85 who have experienced a first-ever unilateral stroke at least three months prior and have moderate to mild upper extremity motor impairment.
Not a fit: Patients with contraindications to tRNS, such as a history of epilepsy or those with certain neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance recovery outcomes for stroke patients by optimizing rehabilitation techniques.
How similar studies have performed: While the combination of tRNS with rehabilitation therapies is a novel approach, existing studies have shown promise in enhancing neural plasticity and recovery in stroke rehabilitation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taoyuan
- Chang Gung Memotial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ching-yi Wu, ScD
- Email: cywu@mail.cgu.edu.tw
- Phone: #886-3-2118800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.