Clinical trial NCT05733858: Comparative Efficacy of Novel Transcranial Random Noise Stimulation Versus Direct Current Stimulation on Augmenting Digital Mirror Therapy in Chronic Stroke
Official title: Comparative Efficacy of Novel Transcranial Random Noise Stimulation Versus Direct
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation (tDCS)
Transcranial Random Noise Stimulation (tRNS)
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 105
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be the first to investigate the effects of novel brain neurotechnology, which is the tRNS combined with digital MT. The investigators will perform a head-to-head comparison of the effects of the innovative tRNS- and tDCS-augmented digital MT interventions comprehensively on clinical, neurophysiological and motor control outcomes in stroke patients. The EEG and kinematic assessment will be used for assessing brain activities and upper extremity motor control. In addition, the investigators will identify the good responders to the tRNS- and tDCS-augmented digital MT interventions to determine the appropriate candidate for the innovative hybrid interventions. The overall findings of this research project will help advance current knowledge of brain neurotechnology and lead to development of neurophysiological and clinical evidence-based brain neurotechnology-augmented digital MT interventions for use in the clinical settings.


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 impairment55;
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
7. willing to provide written informed consent

Exclusion Criteria:

1. contradiction to tRNS and tDCS including a history of epilepsy, pregnant, having pacemakers and metallic implants in the neck and head ;
2. History of drug or alcohol abuse ;
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.

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Modified Ashworth Scale (MAS)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) ) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week), 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Functional Abilities Confidence Scale (FACS)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , 3 -month after completing intervention, 6-month after completing intervention
measure: Change scores of Daily Living Self-Efficacy Scale (DLSES)
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , 3 -month after completing intervention, 6-month after completing intervention
measure: EEG Physiological Assessments
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week)
measure: Kinematic Protocols
timeFrame: Baseline, posttest(after completing the intervention,often baseline after 4 week)
Secondary outcomes:
Other outcomes:
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