Transcranial Alternating Current Stimulation for Hand Function Recovery

NCT04638192 | Unknown

• 1 other identifier: 2017.663
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Magnetic resonance imaging

  Structural and functional MRI

  3-month after the 10th session training

Secondary Outcomes (3)

• Action Research Arm Test (ARAT)

  3-month after the 10th session training

• Fugl-Meyer Assessment (Upper Extremity)

  3-month after the 10th session training

• Wolf Motor Function Test (WMFT)

  3-month after the 10th session training

Study Arms (3)

subject-specific tACS

EXPERIMENTAL

Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency

Device: tACS

standard tACS

EXPERIMENTAL

Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency

Device: tACS

Sham tACS

SHAM COMPARATOR

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

Device: tACS

Interventions

tACS DEVICE

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

Sham tACS; standard tACS; subject-specific tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond Tong, PhD

  Department of Biomedical Engineering, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

+852 3943 8454; kytong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 20, 2020
• Study Start: December 16, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

HK (1)