StrokeNCT07085910
Hebbian-Type Associative Stimulation in Stroke Rehabilitation
A study testing Transcranial magnetic stimulation - dual coil and Transcranial magnetic stimulation in people with Stroke, run by The Hong Kong Polytechnic University.
Trial summary
Stroke remains the primary cause of long-term neurological disabilities. Effective rehabilitation solutions are essential to alleviate the burden poststroke survivors impose on hospitals and community services. Following unilateral stroke, interhemispheric balance is disrupted. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial magnetic stimulation - dual coil and Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with monohemispheric ischemic subcortical stroke (with intact corpus callosum), with stroke onset ≥6 months,
- Age 40-75 years.
- Residual upper limb function between levels 3-6, according to the Functional Test for the Hemiplegic Upper Extremity (FTHUE), indicating mildly to moderately impaired upper limb motor function.
- Capable of providing informed written consent.
Who cannot join
- any contraindications for TMS (screened using the safety checklist by Rossi)
- Diagnosis of any concomitant neurological diseases other than stroke.
- Signs of cognitive impairment, defined as a Montreal cognitive assessment Hong Kong version score <21/22 out of 30 .
- Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score >2.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Modulating Interhemispheric Interactions Using Hebbian-Type Associative Stimulation to Promote Upper Extremity Motor Recovery Following Stroke
Stroke remains the primary cause of long-term neurological disabilities. Effective rehabilitation solutions are essential to alleviate the burden poststroke survivors impose on hospitals and community services. Following unilateral stroke, interhemispheric balance is disrupted. Prior studies have extensively documented that exaggerated interhemispheric inhibitory flow from the contralesional to the ipsilesional hemisphere prevents maximal functional recovery in poststroke survivors. Therefore, we aimed to test the modulatory effects of a Hebbian-type plasticity induction paradigm using corticocortical paired associative stimulation (ccPAS) over the bilateral motor cortex. This approach aims to reverse the abnormal inhibitory flow from the contralesional to the ipsilesional hemisphere and assess its clinical benefits on upper extremity motor recovery in patients with stroke. In this randomized controlled trial, we hypothesize that Hebbian-type ccPAS would be more effective than sham ccPAS and conventional single-site inhibitory rTMS delivered to the contralesional hemisphere at improving hemiplegic upper limb motor functionality and modulating interhemispheric activity to an equilibrium state among patients with stroke. This approach seeks to address diseases related to brain network impairments, such as stroke. This project will provide insights into the recovery mechanisms activated following neurological diseases from the perspective of the Hebbian learning rules of associative plasticity.
- Conditions
- Stroke
- Being tested
- Transcranial magnetic stimulation - dual coil, Transcranial magnetic stimulation
- Keywords
- Stroke, Neuromodulation, Transcranial magnetic stimulation, Upper extremity, Rehabilitation and Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation - dual coilDevice
The dual coil stimulation will be applied using two MagPro X100 stimulators connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation.
Transcranial magnetic stimulationDevice
Single coil TMS will be performed using a TMS stimulator and the same stimulation coil (MC-B65-HO).
| Study group | Role | What they receive |
|---|---|---|
| Corticocortical paired associative stimulation (ccPAS) | Experimental | The ccPAS will be applied using two MagPro X100 stimulators connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation. Each ccPAS session will involve the delivery of 90 paired pulses, stimulating the M1s over both the contralesional and ipsilesional hemispheres at a frequency of 0.05 Hz. Each session will be 30 minutes, and the interstimulus interval between paired pulses will be 8 ms to ensure that the ipsilesional M1 neurons are always activated before the firing of contralesional M1 neurons. Receives: Device: Transcranial magnetic stimulation - dual coil |
| Conventional single-site low frequency repetitive transcranial magnetic stimulation (rTMS) | Active comparator | LF rTMS will be performed using a TMS stimulator and the same stimulation coil (MC-B65-HO). The stimulation target will be set the contralesional M1 area, determined using motor hotspot hunting. In line with our recent trial, a total of 1200 pulses (20 mins) with a frequency of 1 Hz and an intensity of 120% of the RMT will be delivered to the contralesional M1 Receives: Device: Transcranial magnetic stimulation |
| Sham corticocortical paired associative stimulation (ccPAS) | Sham comparator | The same dual-coil setup (MC-B65-HO) and stimulation intensity during sham stimulation as in the ccPAS group will be utilized. However, the inter-stimulus interval between paired pulses will be adjusted to 100 ms (a duration that prevents any STDP-like effects from being induced by repetitive paired-pulse stimulation) Receives: Device: Transcranial magnetic stimulation - dual coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Assessment-Upper Extremity Scores
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.
Measured: Baseline
The Fugl-Meyer Assessment-Upper Extremity Scores
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.
Measured: At 4 weeks
The Fugl-Meyer Assessment-Upper Extremity Scores
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.
Measured: At 3-month
Secondary outcomes (3)
Interhemispheric signal propagation (ISP) in TMS-evoked potential
ISP measured using concurrent TMS-evoked potential is set as another outcome for measuring the interhemispheric inhibitory flow between the bilateral M1s. TMS-evoked activity will be defined as the local mean field power (LMFP) of six channels surrounding the M1 (Left: C1, C3, C5, CP1, CP3, CP5; Right: C2, C4, C6, CP2, CP4, CP6) in a specific time frame. Because of the approximately 10 ms of transcallosal conduction, the LMFP from 50 to 130 ms is rectified for the stimulated M1 and from 60 to 140 ms for the non-stimulated M1. A higher ISP value indicates a higher inhibitory flow from the non-stimulated M1 to the stimulated M1.
Measured: Baseline
Interhemispheric signal propagation (ISP) in TMS-evoked potential
ISP measured using concurrent TMS-evoked potential is set as another outcome for measuring the interhemispheric inhibitory flow between the bilateral M1s. TMS-evoked activity will be defined as the local mean field power (LMFP) of six channels surrounding the M1 (Left: C1, C3, C5, CP1, CP3, CP5; Right: C2, C4, C6, CP2, CP4, CP6) in a specific time frame. Because of the approximately 10 ms of transcallosal conduction, the LMFP from 50 to 130 ms is rectified for the stimulated M1 and from 60 to 140 ms for the non-stimulated M1. A higher ISP value indicates a higher inhibitory flow from the non-stimulated M1 to the stimulated M1.
Measured: At 4-week
Interhemispheric signal propagation (ISP) in TMS-evoked potential.
ISP measured using concurrent TMS-evoked potential is set as another outcome for measuring the interhemispheric inhibitory flow between the bilateral M1s. TMS-evoked activity will be defined as the local mean field power (LMFP) of six channels surrounding the M1 (Left: C1, C3, C5, CP1, CP3, CP5; Right: C2, C4, C6, CP2, CP4, CP6) in a specific time frame. Because of the approximately 10 ms of transcallosal conduction, the LMFP from 50 to 130 ms is rectified for the stimulated M1 and from 60 to 140 ms for the non-stimulated M1. A higher ISP value indicates a higher inhibitory flow from the non-stimulated M1 to the stimulated M1.
Measured: At 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Dec 2028 (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 The Hong Kong Polytechnic UniversityThe 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085910
- Sponsor's protocol ID
- HSEARS20240927001
- Status last verified
- Jun 2025
- First submitted
- 17 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Interhemispheric Interactions Using Hebbian-Type Associative Stimulation to Promote Upper Extremity Motor Recovery Following Stroke
- ClinicalTrials.gov ID
- NCT07085910
- Acronym / sponsor ID
- HSEARS20240927001
- Conditions
- Stroke
- Keywords
- Stroke, Neuromodulation, Transcranial magnetic stimulation, Upper extremity, Rehabilitation and Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jul 2025 (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.
Stroke remains the primary cause of long-term neurological disabilities. Effective rehabilitation solutions are essential to alleviate the burden poststroke survivors impose on hospitals and community services. Following unilateral stroke, interhemispheric balance is disrupted. Prior studies have extensively documented that exaggerated interhemispheric inhibitory flow from the contralesional to the ipsilesional hemisphere prevents maximal functional recovery in poststroke survivors. Therefore, we aimed to test the modulatory effects of a Hebbian-type plasticity induction paradigm using corticocortical paired associative stimulation (ccPAS) over the bilateral motor cortex. This approach aims to reverse the abnormal inhibitory flow from the contralesional to the ipsilesional hemisphere and assess its clinical benefits on upper extremity motor recovery in patients with stroke. In this randomized controlled trial, we hypothesize that Hebbian-type ccPAS would be more effective than sham ccPAS and conventional single-site inhibitory rTMS delivered to the contralesional hemisphere at improving hemiplegic upper limb motor functionality and modulating interhemispheric activity to an equilibrium state among patients with stroke. This approach seeks to address diseases related to brain network impairments, such as stroke. This project will provide insights into the recovery mechanisms activated following neurological diseases from the perspective of the Hebbian learning rules of associative plasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corticocortical paired associative stimulation (ccPAS) | Experimental | Device: Transcranial magnetic stimulation - dual coilThe ccPAS will be applied using two MagPro X100 stimulators connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation. Each ccPAS session will involve the delivery of 90 paired pulses, stimulating the M1s over both the contralesional and ipsilesional hemispheres at a frequency of 0.05 Hz. Each session will be 30 minutes, and the interstimulus interval between paired pulses will be 8 ms to ensure that the ipsilesional M1 neurons are always activated before the firing of contralesional M1 neurons. |
| Conventional single-site low frequency repetitive transcranial magnetic stimulation (rTMS) | Active comparator | Device: Transcranial magnetic stimulationLF rTMS will be performed using a TMS stimulator and the same stimulation coil (MC-B65-HO). The stimulation target will be set the contralesional M1 area, determined using motor hotspot hunting. In line with our recent trial, a total of 1200 pulses (20 mins) with a frequency of 1 Hz and an intensity of 120% of the RMT will be delivered to the contralesional M1 |
| Sham corticocortical paired associative stimulation (ccPAS) | Sham comparator | Device: Transcranial magnetic stimulation - dual coilThe same dual-coil setup (MC-B65-HO) and stimulation intensity during sham stimulation as in the ccPAS group will be utilized. However, the inter-stimulus interval between paired pulses will be adjusted to 100 ms (a duration that prevents any STDP-like effects from being induced by repetitive paired-pulse stimulation) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis with monohemispheric ischemic subcortical stroke (with intact corpus callosum), with stroke onset ≥6 months,
- Age 40-75 years.
- Residual upper limb function between levels 3-6, according to the Functional Test for the Hemiplegic Upper Extremity (FTHUE), indicating mildly to moderately impaired upper limb motor function.
- Capable of providing informed written consent.
Key exclusion criteria (4 listed)
- any contraindications for TMS (screened using the safety checklist by Rossi)
- Diagnosis of any concomitant neurological diseases other than stroke.
- Signs of cognitive impairment, defined as a Montreal cognitive assessment Hong Kong version score <21/22 out of 30 .
- Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score >2.
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 |
|---|---|---|
| Transcranial magnetic stimulation - dual coilThe dual coil stimulation will be applied using two MagPro X100 stimulators connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation. | Device | Corticocortical paired associative stimulation (ccPAS), Sham corticocortical paired associative stimulation (ccPAS) |
| Transcranial magnetic stimulationSingle coil TMS will be performed using a TMS stimulator and the same stimulation coil (MC-B65-HO). | Device | Conventional single-site low frequency repetitive transcranial magnetic stimulation (rTMS) |
Primary outcome
The Fugl-Meyer Assessment-Upper Extremity Scores
Time frame: Baseline
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.
The Fugl-Meyer Assessment-Upper Extremity Scores
Time frame: At 4 weeks
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.
The Fugl-Meyer Assessment-Upper Extremity Scores
Time frame: At 3-month
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for assessing poststroke upper limb motor control. It is used to determine the movement, coordination, and reflex action of the affected upper limb in poststroke people.
3 secondary outcomes
Interhemispheric signal propagation (ISP) in TMS-evoked potential
Time frame: Baseline
Interhemispheric signal propagation (ISP) in TMS-evoked potential
Time frame: At 4-week
Interhemispheric signal propagation (ISP) in TMS-evoked potential.
Time frame: At 3-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation - dual coil and Transcranial magnetic stimulation in people with Stroke, run by The Hong Kong Polytechnic University.
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 4 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: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack Jiaqi Zhang, PhD (27666696, jack-jiaqi.zhang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fugl-Meyer Assessment-Upper Extremity Scores (time frame: Baseline). The study lists 3 primary outcomes in all. 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 25 Jul 2025.