StrokeNCT02731508
Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke
A study testing Bihemispheric transcranial direct current stimulation in people with Stroke, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bihemispheric transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2015to Oct 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80 years old
- Patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness
- Brain MRI confirmed subcortical stroke in the middle cerebral artery territory
- Post-stroke 2-6 weeks with stable clinical condition
Who cannot join
- Stroke with cortical lesions
- Containing metal implants (such as implanted electrodes, pacemakers)
- Sensitive or fear of electromagnetic waves
- Pregnant women
- History of alcohol or drug abuse
- History of seizures or epilepsy
- Claustrophobia
- Other significant disease or neuropsychiatric disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
i-hui Lee, MD, PhD, 886-2-28712121 ext. 8109, ihui_lee@hotmail.com
i-hui Lee, MD, PhD
About this study
Official title: Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke
Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. In this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.
Read the detailed description
Investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be randomly allocated to receive daily bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or daily sham tDCS (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. Changes in upper extremity motor function score (Fugl-Meyer test and Action Research Arm test), corticospinal excitability from the transcranial magnetic stimulation(TMS), and sensorimotor oscillations from the magnetoencephalography (MEG) will be assessed before and after intervention, as well as 3 months after stroke. All stroke patients will receive tDCS and standard medical, rehabilitation treatments in rehabilitation ward.
- Conditions
- Stroke
- Being tested
- Bihemispheric transcranial direct current stimulation
- Keywords
- Transcranial Direct Current Stimulation, Neuroplasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bihemispheric transcranial direct current stimulationDevice
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| True stimulation | Experimental | True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions Receives: Device: Bihemispheric transcranial direct current stimulation |
| Sham stimulation | Sham comparator | Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds Receives: Device: Bihemispheric transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer test
stroke motor function scale
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary outcomes (9)
Action Research Arm test
stroke motor function scale
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Modified Rankin Scale
Global disability poststroke
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Resting state functional connectivity
Functional MRI
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor evoked potential
Transcranial magnetic stimulation test
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Active motor threshold
Transcranial magnetic stimulation test
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Ipsilateral silent period
Transcranial magnetic stimulation test
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Short interval intracortical inhibition
Transcranial magnetic stimulation test
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERD peak amplitude
magnetoencephalography
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERS peak amplitude
magnetoencephalography
Measured: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731508
- Sponsor's protocol ID
- 2015-03-003C
- Status last verified
- Nov 2021
- First submitted
- 15 Feb 2016
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hsu SP, Lu CF, Lin BF, Tang CW, Kuo IJ, Tsai YA, Guo CY, Lee PL, Shyu KK, Niddam DM, Lee IH. Effects of bihemispheric transcranial direct current stimulation on motor recovery in subacute stroke patients: a double-blind, randomized sham-controlled trial. J Neuroeng Rehabil. 2023 Feb 27;20(1):27. doi: 10.1186/s12984-023-01153-4.
PubMed 36849990
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke
- ClinicalTrials.gov ID
- NCT02731508
- Acronym / sponsor ID
- 2015-03-003C
- Conditions
- Stroke
- Keywords
- Transcranial Direct Current Stimulation, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Oct 2015
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- 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.
Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. In this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.
Detailed description
Investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be randomly allocated to receive daily bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or daily sham tDCS (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. Changes in upper extremity motor function score (Fugl-Meyer test and Action Research Arm test), corticospinal excitability from the transcranial magnetic stimulation(TMS), and sensorimotor oscillations from the magnetoencephalography (MEG) will be assessed before and after intervention, as well as 3 months after stroke. All stroke patients will receive tDCS and standard medical, rehabilitation treatments in rehabilitation ward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True stimulation | Experimental | Device: Bihemispheric transcranial direct current stimulationTrue repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions |
| Sham stimulation | Sham comparator | Device: Bihemispheric transcranial direct current stimulationRepetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-80 years old
- Patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness
- Brain MRI confirmed subcortical stroke in the middle cerebral artery territory
- Post-stroke 2-6 weeks with stable clinical condition
Key exclusion criteria (8 listed)
- Stroke with cortical lesions
- Containing metal implants (such as implanted electrodes, pacemakers)
- Sensitive or fear of electromagnetic waves
- Pregnant women
- History of alcohol or drug abuse
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 |
|---|---|---|
| Bihemispheric transcranial direct current stimulation5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation | Device | Sham stimulation, True stimulation |
Primary outcome
Fugl-Meyer test
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
stroke motor function scale
9 secondary outcomes
Action Research Arm test
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Modified Rankin Scale
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Resting state functional connectivity
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor evoked potential
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Active motor threshold
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Ipsilateral silent period
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Short interval intracortical inhibition
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERD peak amplitude
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERS peak amplitude
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 36849990Hsu SP, Lu CF, Lin BF, Tang CW, Kuo IJ, Tsai YA, Guo CY, Lee PL, Shyu KK, Niddam DM, Lee IH. Effects of bihemispheric transcranial direct current stimulation on motor recovery in subacute stroke patients: a double-blind, randomized sham-controlled trial. J Neuroeng Rehabil. 2023 Feb 27;20(1):27. doi: 10.1186/s12984-023-01153-4.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bihemispheric transcranial direct current stimulation in people with Stroke, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 inclusion and 8 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 30 Nov 2021. 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 Taiwan. 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 I-Hui Lee, M.D., Ph.D. (+ 886-2-28712121 ext. 8109, ihlee@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer test (time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02731508, which also lists 1 linked publication.
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 30 Nov 2021.