RECRUITINGINTERVENTIONAL

Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Transcranial random noise stimulation (tRNS)

There will be 20 minutes of stimulation (real tRNS or sham tRNS), 40 minutes of MT (unilateral or bilateral) and 30 minutes of functional task training.

DEVICE

sham tRNS

the electrode placement will be the same as the real stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds

BEHAVIORAL

the unilateral MT

For the unilateral MT, the participants will practice movements using only the unaffected arm while the affected arm will remain relaxed behind the mirror during MT training. The training therapists will instruct the participants to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task.

BEHAVIORAL

the bilateral MT

For the bilateral MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand during MT training. At the same time, participants will also be instructed to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task. The activities practiced during MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen).

Locations (1)

Chang Gung Memotial Hospital

Taoyuan District, Taiwan