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Transcranial Alternating Current Stimulation for Hand Function Recovery

NCT ID: NCT04638192

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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subject-specific tACS

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

Group Type EXPERIMENTAL

tACS

Intervention Type DEVICE

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

standard tACS

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

Group Type EXPERIMENTAL

tACS

Intervention Type DEVICE

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

Sham 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

Group Type SHAM_COMPARATOR

tACS

Intervention Type DEVICE

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

Interventions

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tACS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Chairman and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, The Chinese University of Hong Kong

Locations

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Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Raymond Tong, PhD

Role: CONTACT

Phone: +852 3943 8454

Email: [email protected]

Facility Contacts

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Raymond Tong, PhD

Role: primary

Other Identifiers

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2017.663

Identifier Type: -

Identifier Source: org_study_id