NCT05238272

Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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 a promising brain neurotechnology to enhance neural plasticity to augment treatment effects of stroke neuorehabilitation therapies. Compared to traditional brain neurotechnology such as transcranial direct current stimulation (tDCS), tRNS does not have polarity constraints, thus providing more consistent modulatory effects, less response variability and less adverse effects, which make it a potentially ideal approach to combine with stroke rehabilitation therapies. Mirror therapy (MT) is effective at improving sensorimotor recovery in stroke patients. Because of its easiness for use in clinical settings, MT has been recommended by American Heart Association as a promising intervention for stroke patients. Combining tRNS with MT could be an appealing approach to further boost brain plasticity to maximize MT treatment benefits in the clinical settings. However, MT can be delivered using unilateral or bilateral approaches, which may induce differential treatment benefits. Identifying the optimal combination of MT with tRNS on recovering functions and brain mechanisms will be imperative for development of evidence-based precision brain neurotechnology-augmented stroke rehabilitation. Therefore, this research project will (1) compare 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) comprehensively on motor function, daily function, quality of life and self-efficacy, motor control strategy and brain activities (electroencephalography, EEG) in stroke patients; (2) examine the retention effects and possible delayed response of tRNS-augmented unilateral and bilateral MT at 3-month and 6-month follow-up and (3) identify the predictors of the treatment success to determine good responders to the tRNS-augmented unilateral and bilateral MT to facilitate clinical translation of the intervention. The investigator will conduct a randomized, sham controlled clinical trial with 128 stroke patients in this 5-year project. Patients will be randomly assigned to (1) tRNS-augmented unilateral MT, (2) tRNS-augmented bilateral MT, (3) sham tRNS with unilateral MT, and (4) sham tRNS with bilateral MT. Participants will receive 20 intervention sessions (90 minutes/day, 5 days/week, for 4 consecutive weeks). The outcome measures will include behavioral assessments to evaluate motor and daily function, quality of life and self-efficacy; kinematic assessments to evaluate motor control strategy; and EEG to assess brain activities (power). The behavioral measures will be performed at pre-test, interim-test, post-test, and 3-month and 6-month follow-up. The kinematic and EEG assessment will be administered at pre-test and post-test. In addition, the EEG assessment will be conducted during the intervention period to evaluate the dynamical changes of brain activities. This research project will provide scientific evidence of the treatment effects of brain neurotechnology-augmented stroke rehabilitation therapy. Specifically, the findings will elucidate behavioral changes and possible biomechanical and brain mechanisms associated with the novel tRNS-augmented MT. In addition, the results will reveal the characteristics of good responders to the combined intervention. The overall results will contribute to formulation of precision hybrid brain neurotechnology with stroke rehabilitation therapies to maximize neural and functional recovery after stroke.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-02-14
• Last updated: 2022-02-14

Locations

1 site across 1 country: Taiwan