Transcranial Alternating Current Stimulation for Hand Function Recovery

Stroke Clinical Trial

Official title:

Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638192
• Other study ID #: 2017.663
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Chinese University of Hong Kong
• Contact: Raymond Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tACS
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic resonance imaging	Structural and functional MRI	3-month after the 10th session training
Secondary	Action Research Arm Test (ARAT)	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).	3-month after the 10th session training
Secondary	Fugl-Meyer Assessment (Upper Extremity)	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.	3-month after the 10th session training
Secondary	Wolf Motor Function Test (WMFT)	The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).	3-month after the 10th session training