Transcranial Alternating Current Stimulation for Hand Function Recovery
November 17, 2020 updated by: Raymond KY Tong, Chinese University of Hong Kong
Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Shatin, Hong Kong
- Recruiting
- Department of Biomedical Engineering, The Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: subject-specific tACS
Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency
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A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
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Experimental: standard tACS
Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency
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A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
|
|
Sham Comparator: 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
|
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnetic resonance imaging
Time Frame: 3-month after the 10th session training
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Structural and functional MRI
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3-month after the 10th session training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test (ARAT)
Time Frame: 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).
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3-month after the 10th session training
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Fugl-Meyer Assessment (Upper Extremity)
Time Frame: 3-month after the 10th session training
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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.
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3-month after the 10th session training
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Wolf Motor Function Test (WMFT)
Time Frame: 3-month after the 10th session training
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The WMFT measures upper limb ability through timed and functional tasks.
It has 17 items, ranging from 0 to 5 (worse to best).
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3-month after the 10th session training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raymond Tong, PhD, Department of Biomedical Engineering, The Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 17, 2020
First Posted (Actual)
November 20, 2020
Study Record Updates
Last Update Posted (Actual)
November 20, 2020
Last Update Submitted That Met QC Criteria
November 17, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017.663
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.