NCT05733858

Comparative Efficacy of Novel Transcranial Random Noise Stimulation Versus Direct Current Stimulation on Augmenting Digital Mirror Therapy in Chronic Stroke

Comparative Efficacy of Novel Transcranial Random Noise Stimulation Versus Direct

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcranial Direct Current Stimulation (tDCS)
• Transcranial Random Noise Stimulation (tRNS)

Interventions

Type	Name	Description
DEVICE	tRNS	For tRNS, the electrical current is delivered alternatively (an alternating current). The stimulation intensity will be set as 1.5 to 2 mA (based on the tolerance of participants). The stimulation frequency will be random frequencies ranging from 101 and 640 Hz.The stimulation period of tRNS and tDCS will be 20 minutes.
DEVICE	tDCS	For tDCS, the electrical current is delivered in a continuous and consistent manner (direct current). The stimulation intensity will be the same as that of tRNS (1.5 to 2 mA based on the tolerance of participants), which is safe for stroke patients.The stimulation period of tRNS and tDCS will be 20 minutes.
DEVICE	sham stimulation	For the sham stimulation condition, the electrode placement will be the same as the other real eletrical stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds to provide sensory feeling without actually stimulating the brain.
BEHAVIORAL	digital MT	For the digital MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand while looking at the real-time image on the computer screen. The activities practiced during digital MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen). The amount of time exposed to intransitive and transitive movements will be balanced for each participant. The participants will practice 30 intransitive and 30 transitive tasks over the 20 training sessions, and the actual movements will be selected based on each individual's ability and his/her needs.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-02-17
• Last updated: 2023-02-17