Transcranial Alternating Current Stimulation for Hand Function Recovery

Not Applicable

• Conditions: Stroke
• Interventions: Device: tACS

• Registration Number: NCT04638192
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

tACS has the potential to directly induce cortical alterations in the intrinsic neural oscillation at specific frequencies, and the brain could mirror the induced frequencies of the external source of oscillations from the stimulation. Hence, tACS with matching stimulation frequency could be an effective means of enhancing brain oscillatory activity to potentially induce synaptic plasticity for restoration of damaged brain functions. However from the existing studies of applying tACS over the M1 in healthy and diseased brains, there is a wide range of applied stimulation frequencies and varied neuromodulation effects on motor behavior or cortical excitability at different frequencies. In this proposal, subject-specific stimulation frequency and latency will be identified.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-16
• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-20
• Last Update Posted: 2020-11-20
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
• MCP and PIP finger joints can be extended to 180° passively;
• Sufficient cognition to follow the experimental instructions

Exclusion Criteria

• Severe hand spasticity or hand deformity;
• History of alcohol or drug abuse or epilepsy;
• Bilateral brain infarcts;
• Severe cognitive deficits;
• Comprehensive aphasia;
• Contraindications to tACS and MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard tACS	tACS	Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency
subject-specific tACS	tACS	Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency
Sham tACS	tACS	The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging	3-month after the 10th session training	Structural and functional MRI

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	3-month after the 10th session training	The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).
Fugl-Meyer Assessment (Upper Extremity)	3-month after the 10th session training	The maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.
Wolf Motor Function Test (WMFT)	3-month after the 10th session training	The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong