StrokeNCT06241508
The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study
A study testing Transcranial magnetic stimulation in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Feb 2024to 30 May 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) have a diagnosis of ischemic or hemorrhagic stroke, with time after stroke onset≥6 months;
- (2) aged between 18 and 80 years old;
- (3) with residual upper limb functions from 2-7 levels in the Functional Test for the Hemiplegic Upper Extremity, i.e., moderately impaired overall upper extremity functions.
- (4) able to give informed written consent to participate in the study.
Who cannot join
- (1) any contraindications to TMS (screened by the safety checklist by Rossi [12]); -
- (2) any concomitant neurological disease;
- (3) any sign of moderate-to-severe cognitive problems, i.e., Montreal cognitive assessment (MoCA)<19/30
- (4) Modified Ashworth score>2 in hand, wrist or elbow extensor muscle in the hemiparetic upper extremity.
- In addition, a group of age-matched, right-hand dominant healthy adults without any known neurological diseases will be enrolled. Healthy adults with any contraindications to TMS will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.
Methods: 20 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold [RMT] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.
Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.
Read the detailed description
Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.
Methods: 20 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold [RMT] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.
Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.
- Conditions
- Stroke
- Being tested
- Transcranial magnetic stimulation
- Keywords
- stroke, transcranial magnetic stimulation, theta burst stimulation, neuroplasticity, motor learning
- 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 stimulationDevice
A standard 600-pulse TBS [16] will be administrated using a MagPro X100 stimulator (MagVenture, Denmark) and a 65-mm figure-of-eight coil. The measurement of the motor hotspot and individual RMT will be in accordance with our established methodology [3, 9]. For patients with stroke, the intensity of real stimulation will be 55% or 70% RMT of the unaffected M1 [17], depending on their assigned condition. Sham stimulation will be delivered using the same coil with 20% RMT of the unaffected M1 [4, 6]. The priming and conditioning sessions will be delivered to the ipsilesional M1 sequentially. In line with previous works, the interval between them will be 10 minutes [2, 3]. For healthy adults, the stimulation will be applied exclusively to the non-dominant (right) M1.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity priming intermittent theta burst stimulation | Experimental | Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability.
In the present study, real stimulation will be delivered in an intensity of 55% (low-intensity) or 70% (conventional intensity) individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% (ineffective) individual resting motor threshold.
Low-intensity priming intermittent theta burst stimulation will use a session of 55% RMT cTBS followed by a session of 70% RMT iTBS. Both sessions will be applied to the ipsilesional primary motor cortex. Receives: Device: Transcranial magnetic stimulation |
| Conventional intensity priming intermittent theta burst stimulation | Experimental | Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability.
In the present study, real stimulation will be delivered in an intensity of 55% (low-intensity) or 70% (conventional intensity) individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% (ineffective) individual resting motor threshold.
Conventional intensity priming intermittent theta burst stimulation will use a session of 70% RMT cTBS followed by a session of 70% RMT iTBS. Both sessions will be applied to the ipsilesional primary motor cortex. Receives: Device: Transcranial magnetic stimulation |
| Standard, nonpriming intermittent theta burst stimulation | Active comparator | Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability.
In the present study, real stimulation will be delivered in an intensity of 55% (low-intensity) or 70% (conventional intensity) individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% (ineffective) individual resting motor threshold.
Nonpriming priming intermittent theta burst stimulation will use a session of 20% RMT cTBS followed by a session of 70% RMT iTBS. Both sessions will be applied to the ipsilesional primary motor cortex. Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The isometric force control task
Force data will be collected using a load cell (Force sensor ZNHM, Chino sensor, China). To assess maximal voluntary contraction (MVC) of the hand grip, three trials will be conducted using both paretic and nonparetic hands (or the dominant and non-dominant hands for healthy controls). Subsequently, separate tests will be performed to measure submaximal isometric force at 20% and 50% of the maximal voluntary force (MVF). Each trial will last for 20 seconds, with a 60-second intertrial interval to prevent fatigue. A total of 5 trials will be conducted for each level of muscle contraction. Muscle strength will be evaluated by calculating the mean force output, while the variability of force control will be assessed by calculating the coefficient of variation of force, i.e., the standard deviation of force/mean force output × 100%.
Measured: Baseline
The isometric force control task
Force data will be collected using a load cell (Force sensor ZNHM, Chino sensor, China). To assess maximal voluntary contraction (MVC) of the hand grip, three trials will be conducted using both paretic and nonparetic hands (or the dominant and non-dominant hands for healthy controls). Subsequently, separate tests will be performed to measure submaximal isometric force at 20% and 50% of the maximal voluntary force (MVF). Each trial will last for 20 seconds, with a 60-second intertrial interval to prevent fatigue. A total of 5 trials will be conducted for each level of muscle contraction. Muscle strength will be evaluated by calculating the mean force output, while the variability of force control will be assessed by calculating the coefficient of variation of force, i.e., the standard deviation of force/mean force output × 100%.
Measured: 15-min after completion of stimulation sessions
Transcranial magnetic stimulation-evoked potential
Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.
Measured: Baseline
Transcranial magnetic stimulation-evoked potential
Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.
Measured: 5-min after completion of stimulation sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Feb 2024
- Primary completion10 Mar 2025
- Study completion30 May 2025
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT06241508
- Sponsor's protocol ID
- HSEARS20231104003
- Status last verified
- Dec 2023
- First submitted
- 24 Jan 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study
- ClinicalTrials.gov ID
- NCT06241508
- Acronym / sponsor ID
- HSEARS20231104003
- Conditions
- Stroke
- Keywords
- stroke, transcranial magnetic stimulation, theta burst stimulation, neuroplasticity, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 5 Feb 2024 (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.
Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.
Methods: 20 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold [RMT] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.
Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.
Detailed description
Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.
Methods: 20 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold [RMT] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.
Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-intensity priming intermittent theta burst stimulation | Experimental | Device: Transcranial magnetic stimulationTheta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 55% (low-intensity) or 70% (conventional intensity) individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% (ineffective) individual resting motor threshold. Low-intensity priming intermittent theta burst stimulation will use a session of 55% RMT cTBS followed by a session of 70% RMT iTBS. Both sessions will be applied to the ipsilesional primary motor cortex. |
| Conventional intensity priming intermittent theta burst stimulation | Experimental | Device: Transcranial magnetic stimulationTheta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 55% (low-intensity) or 70% (conventional intensity) individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% (ineffective) individual resting motor threshold. Conventional intensity priming intermittent theta burst stimulation will use a session of 70% RMT cTBS followed by a session of 70% RMT iTBS. Both sessions will be applied to the ipsilesional primary motor cortex. |
| Standard, nonpriming intermittent theta burst stimulation | Active comparator | Device: Transcranial magnetic stimulationTheta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 55% (low-intensity) or 70% (conventional intensity) individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% (ineffective) individual resting motor threshold. Nonpriming priming intermittent theta burst stimulation will use a session of 20% RMT cTBS followed by a session of 70% RMT iTBS. Both sessions will be applied to the ipsilesional primary motor cortex. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) have a diagnosis of ischemic or hemorrhagic stroke, with time after stroke onset≥6 months;
- (2) aged between 18 and 80 years old;
- (3) with residual upper limb functions from 2-7 levels in the Functional Test for the Hemiplegic Upper Extremity, i.e., moderately impaired overall upper extremity functions.
- (4) able to give informed written consent to participate in the study.
Key exclusion criteria (5 listed)
- (1) any contraindications to TMS (screened by the safety checklist by Rossi [12]); -
- (2) any concomitant neurological disease;
- (3) any sign of moderate-to-severe cognitive problems, i.e., Montreal cognitive assessment (MoCA)<19/30
- (4) Modified Ashworth score>2 in hand, wrist or elbow extensor muscle in the hemiparetic upper extremity.
- In addition, a group of age-matched, right-hand dominant healthy adults without any known neurological diseases will be enrolled. Healthy adults with any contraindications to TMS will be excluded.
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 stimulationA standard 600-pulse TBS [16] will be administrated using a MagPro X100 stimulator (MagVenture, Denmark) and a 65-mm figure-of-eight coil. The measurement of the motor hotspot and individual RMT will be in accordance with our established methodology [3, 9]. For patients with stroke, the intensity of real stimulation will be 55% or 70% RMT of the unaffected M1 [17], depending on their assigned condition. Sham stimulation will be delivered using the same coil with 20% RMT of the unaffected M1 [4, 6]. The priming and conditioning sessions will be delivered to the ipsilesional M1 sequentially. In line with previous works, the interval between them will be 10 minutes [2, 3]. For healthy adults, the stimulation will be applied exclusively to the non-dominant (right) M1. | Device | Conventional intensity priming intermittent theta burst stimulation, Low-intensity priming intermittent theta burst stimulation, Standard, nonpriming intermittent theta burst stimulation |
Primary outcome
The isometric force control task
Time frame: Baseline
Force data will be collected using a load cell (Force sensor ZNHM, Chino sensor, China). To assess maximal voluntary contraction (MVC) of the hand grip, three trials will be conducted using both paretic and nonparetic hands (or the dominant and non-dominant hands for healthy controls). Subsequently, separate tests will be performed to measure submaximal isometric force at 20% and 50% of the maximal voluntary force (MVF). Each trial will last for 20 seconds, with a 60-second intertrial interval to prevent fatigue. A total of 5 trials will be conducted for each level of muscle contraction. Muscle strength will be evaluated by calculating the mean force output, while the variability of force control will be assessed by calculating the coefficient of variation of force, i.e., the standard deviation of force/mean force output × 100%.
The isometric force control task
Time frame: 15-min after completion of stimulation sessions
Force data will be collected using a load cell (Force sensor ZNHM, Chino sensor, China). To assess maximal voluntary contraction (MVC) of the hand grip, three trials will be conducted using both paretic and nonparetic hands (or the dominant and non-dominant hands for healthy controls). Subsequently, separate tests will be performed to measure submaximal isometric force at 20% and 50% of the maximal voluntary force (MVF). Each trial will last for 20 seconds, with a 60-second intertrial interval to prevent fatigue. A total of 5 trials will be conducted for each level of muscle contraction. Muscle strength will be evaluated by calculating the mean force output, while the variability of force control will be assessed by calculating the coefficient of variation of force, i.e., the standard deviation of force/mean force output × 100%.
Transcranial magnetic stimulation-evoked potential
Time frame: Baseline
Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.
Transcranial magnetic stimulation-evoked potential
Time frame: 5-min after completion of stimulation sessions
Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Stroke, run by The Hong Kong Polytechnic University 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jun 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The isometric force control task (time frame: Baseline). The study lists 4 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 13 Jun 2025.