StrokeNCT04638192
Transcranial Alternating Current Stimulation for Hand Function Recovery
A study testing tACS in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Dec 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Shatin
Raymond Tong, PhD
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- tACS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
| Study group | Role | What they receive |
|---|---|---|
| subject-specific tACS | Experimental | Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency Receives: Device: tACS |
| standard tACS | Experimental | Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency Receives: 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 Receives: Device: tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance imaging
Structural and functional MRI
Measured: 3-month after the 10th session training
Secondary outcomes (3)
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).
Measured: 3-month after the 10th session training
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.
Measured: 3-month after the 10th session training
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).
Measured: 3-month after the 10th session training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Dec 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Tong, PhD, Principal investigator, Department of Biomedical Engineering, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638192
- Sponsor's protocol ID
- 2017.663
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery
- ClinicalTrials.gov ID
- NCT04638192
- Acronym / sponsor ID
- 2017.663
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subject-specific tACS | Experimental | Device: tACSConstant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency |
| standard tACS | Experimental | Device: tACSConstant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency |
| Sham tACS | Sham comparator | Device: tACSThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Severe hand spasticity or hand deformity;
- History of alcohol or drug abuse or epilepsy;
- Bilateral brain infarcts;
- Severe cognitive deficits;
- Comprehensive aphasia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACSA pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands. | Device | Sham tACS, standard tACS, subject-specific tACS |
Primary outcome
Magnetic resonance imaging
Time frame: 3-month after the 10th session training
Structural and functional MRI
3 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: 3-month after the 10th session training
Fugl-Meyer Assessment (Upper Extremity)
Time frame: 3-month after the 10th session training
Wolf Motor Function Test (WMFT)
Time frame: 3-month after the 10th session training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
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Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
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Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Tong, PhD principal investigator
Department of Biomedical Engineering, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Tong, PhD (+852 3943 8454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance imaging (time frame: 3-month after the 10th session training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.