StrokeNCT04658745
Effects of Theta Burst Stimulation on Modulation of Mirror Illusion-induced Rhythm Suppression in Stroke
A study testing Intermittent theta burst stimulation and Mirror Therapy in people with Stroke and Hemiplegia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The study aims to test the hypothesis that rTMS in the form of theta burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Intermittent theta burst stimulation and Mirror Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Sep 2020to 31 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type and location of stroke - ischemic or hemorrhagic, cortical or subcortical, confirmed by medical diagnoses compatible with a unilateral lesion involvement;
- Acute stroke patients: stroke with onset of neurological condition ≤3 months, recruited from a local hospital; Chronic stroke patients: stroke with onset of neurological condition from 6 months to 3 years, recruited from self-help organization in the community. The randomization will be pre-stratified into 2 - subacute and chronic stages, and recruit from 2 centers - acute hospital and self-help organizations in the community.
- normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
- right-handed, verified by the Edinburgh Handedness Inventory;
- mild to moderately impaired hemiplegic upper extremity functions, with functional levels 5-7 as rated by the Functional Test for the Hemiplegic Upper Extremity - Hong Kong version (FTHUE-HK);
- the ability to understand and follow simple verbal instructions;
- the ability to participate in a therapy session lasting at least 60 minutes; and
- consent to participate in the study.
Who cannot join
- prior neurological or psychiatric disorders;
- severe spasticity (Modified Ashworth Scale >3) over hemiplegic upper extremity;
- a history of recent Botox injections or acupuncture to the hemiplegic upper extremity within the past three months;
- use of central nervous system-active medicine;
- any contraindication to TMS, according to the guideline of the Safety of TMS Consensus group, such as the risk of epilepsy, metal implants, and pregnancy;
- the presence of unilateral neglect as screened by the Behavioural Inattention Test (CBIT-HK); and
- participation in another clinical study elsewhere during recruitment. Informed written consent will be obtained from all patients prior to data collection.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to test the hypothesis that rTMS in the form of theta burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
Read the detailed description
Stroke is the leading cause of physical disability. Facilitating the process of motor relearning would greatly accelerate the rehabilitation of motor functions and elicit positive neuroplasticity of the damaged brain area. Previous research has already explored the feasibility of motor priming techniques embedded in stroke rehabilitation programs using strategies such as non-invasive brain stimulation (NIBS) and mirror therapy (MT). These treatments are usually implemented along with the standardized rehabilitation, sequentially or simultaneously, and have been demonstrated to be more effective than the standardized rehabilitation programs alone.
Mirror neuron, as indicated traditionally by the decrease in the amplitude of Mu rhythm, i.e. a suppression over central electrodes of electroencephalography (EEG), reflects the "seeing" of movement after "perception". Such oscillations are based on neural substrates that are discharged during the observation and execution of a motor act, which is also associated with other human functions, such as imitation, language, etc. The core mirror neuron system (MNS) is thought to be located in the premotor and the primary sensorimotor cortices, indicating that motor learning could be enhanced during action observation and overt movement.
Preliminary research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) can enhance the corticomotor excitability in mirror neurons during both observation of movement (by others) or imagined movement in healthy subjects; in particular, as measured by enhanced motor evoked potentials (MEP). Increases in MEP has also been induced by short-term action observation and mirror visual feedback in stroke survivors. However, it is not yet known if MNS can be activated by TMS in MT following a stroke, and the relationship between mirror neuron activation and clinical improvements in stroke remains unclear.
The investigators have already published preliminary findings in patients with hemiplegic upper extremity, rTMS, and MT. Here, the investigators propose to test the hypothesis that rTMS in the form of theta-burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
- Conditions
- Stroke, Hemiplegia
- Being tested
- Intermittent theta burst stimulation, Mirror Therapy, Sham intermittent theta burst stimulation, Sham mirror Therapy
- Keywords
- Stroke, upper extremity, intermittent theta burst stimulation, mirror visual feedback, event-related desynchronization
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulationDevice
iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients, by using a butterfly shape coil.
Mirror TherapyBehavioural
Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
Sham intermittent theta burst stimulationDevice
iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. However, a sham coil will be used, which is not associated with any stimulation effect on the brain.
Sham mirror TherapyBehavioural
In sham mirror therapy, the mirror will be covered. Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to move the non-affected hand. The participants cannot receive mirror visual feedback of the paretic upper extremity movement during the therapy. Same as mirror therapy, the movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| iTBS over the ipsilesional primary motor cortex plus mirror therapy | Experimental | iTBS: iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. Receives: Device: Intermittent theta burst stimulation; Behavioral: Mirror Therapy |
| Sham iTBS over the ipsilesional primary motor cortex plus mirror therapy | Sham comparator | iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere, but with a sham coil (i.e., sham iTBS). After the sham stimulation, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. Receives: Behavioral: Mirror Therapy; Device: Sham intermittent theta burst stimulation |
| iTBS to the ipsilesional primary motor cortex plus sham mirror therapy | Sham comparator | iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time, but with a covered mirror (e.g., sham mirror therapy).
In the sham mirror therapy condition, the mirror is covered by a cloth and the participant is instructed to move both arms while looking at a cross mark on the covered mirror and imaging the analogous movements of the affected arm. The movement practice will involve 5 table-top tasks (same as mirror therapy) and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. Receives: Device: Intermittent theta burst stimulation; Behavioral: Sham mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Measured: Baseline
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Measured: 1 day
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Measured: 2 weeks
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Measured: 1-month after the completion of the intervention
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Measured: Baseline (immediately before the first session)
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Measured: 1 day
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Measured: 2 weeks
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Measured: 1-month after the completion of the intervention
Secondary outcomes (16)
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Measured: Baseline (immediately before the first session)
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Measured: 1 day
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Measured: 2 weeks
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Measured: 1-month after the completion of the intervention
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex.
Measured: Baseline (immediately before the first session)
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex.
Measured: 1 day
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex.
Measured: 2 weeks
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex
Measured: 1-month after the completion of the intervention
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Measured: Baseline (immediately before the first session)
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Measured: 1 day
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Measured: 2 weeks
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Measured: 1-month after the completion of the intervention
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Measured: Baseline (immediately before the first session)
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Measured: 1 day
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Measured: 2 weeks
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Measured: 1-month after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start23 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Kenneth Nai Kuen FONG, PHD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658745
- Sponsor's protocol ID
- HSEARS20171106002-01
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 2 Feb 2023
- 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Theta Burst Stimulation on Modulation of Mirror Illusion-induced Rhythm Suppression in Stroke
- ClinicalTrials.gov ID
- NCT04658745
- Acronym / sponsor ID
- HSEARS20171106002-01
- Conditions
- Stroke, Hemiplegia
- Keywords
- Stroke, upper extremity, intermittent theta burst stimulation, mirror visual feedback, event-related desynchronization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Dec 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.
The study aims to test the hypothesis that rTMS in the form of theta burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
Detailed description
Stroke is the leading cause of physical disability. Facilitating the process of motor relearning would greatly accelerate the rehabilitation of motor functions and elicit positive neuroplasticity of the damaged brain area. Previous research has already explored the feasibility of motor priming techniques embedded in stroke rehabilitation programs using strategies such as non-invasive brain stimulation (NIBS) and mirror therapy (MT). These treatments are usually implemented along with the standardized rehabilitation, sequentially or simultaneously, and have been demonstrated to be more effective than the standardized rehabilitation programs alone.
Mirror neuron, as indicated traditionally by the decrease in the amplitude of Mu rhythm, i.e. a suppression over central electrodes of electroencephalography (EEG), reflects the "seeing" of movement after "perception". Such oscillations are based on neural substrates that are discharged during the observation and execution of a motor act, which is also associated with other human functions, such as imitation, language, etc. The core mirror neuron system (MNS) is thought to be located in the premotor and the primary sensorimotor cortices, indicating that motor learning could be enhanced during action observation and overt movement.
Preliminary research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) can enhance the corticomotor excitability in mirror neurons during both observation of movement (by others) or imagined movement in healthy subjects; in particular, as measured by enhanced motor evoked potentials (MEP). Increases in MEP has also been induced by short-term action observation and mirror visual feedback in stroke survivors. However, it is not yet known if MNS can be activated by TMS in MT following a stroke, and the relationship between mirror neuron activation and clinical improvements in stroke remains unclear.
The investigators have already published preliminary findings in patients with hemiplegic upper extremity, rTMS, and MT. Here, the investigators propose to test the hypothesis that rTMS in the form of theta-burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iTBS over the ipsilesional primary motor cortex plus mirror therapy | Experimental | Device: Intermittent theta burst stimulation, Behavioral: Mirror TherapyiTBS: iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. |
| Sham iTBS over the ipsilesional primary motor cortex plus mirror therapy | Sham comparator | Behavioral: Mirror Therapy, Device: Sham intermittent theta burst stimulationiTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere, but with a sham coil (i.e., sham iTBS). After the sham stimulation, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. |
| iTBS to the ipsilesional primary motor cortex plus sham mirror therapy | Sham comparator | Device: Intermittent theta burst stimulation, Behavioral: Sham mirror TherapyiTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time, but with a covered mirror (e.g., sham mirror therapy). In the sham mirror therapy condition, the mirror is covered by a cloth and the participant is instructed to move both arms while looking at a cross mark on the covered mirror and imaging the analogous movements of the affected arm. The movement practice will involve 5 table-top tasks (same as mirror therapy) and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- type and location of stroke - ischemic or hemorrhagic, cortical or subcortical, confirmed by medical diagnoses compatible with a unilateral lesion involvement;
- Acute stroke patients: stroke with onset of neurological condition ≤3 months, recruited from a local hospital; Chronic stroke patients: stroke with onset of neurological condition from 6 months to 3 years, recruited from self-help organization in the community. The randomization will be pre-stratified into 2 - subacute and chronic stages, and recruit from 2 centers - acute hospital and self-help organizations in the community.
- normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
- right-handed, verified by the Edinburgh Handedness Inventory;
- mild to moderately impaired hemiplegic upper extremity functions, with functional levels 5-7 as rated by the Functional Test for the Hemiplegic Upper Extremity - Hong Kong version (FTHUE-HK);
Key exclusion criteria (7 listed)
- prior neurological or psychiatric disorders;
- severe spasticity (Modified Ashworth Scale >3) over hemiplegic upper extremity;
- a history of recent Botox injections or acupuncture to the hemiplegic upper extremity within the past three months;
- use of central nervous system-active medicine;
- any contraindication to TMS, according to the guideline of the Safety of TMS Consensus group, such as the risk of epilepsy, metal implants, and pregnancy;
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 |
|---|---|---|
| Intermittent theta burst stimulationiTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients, by using a butterfly shape coil. | Device | iTBS over the ipsilesional primary motor cortex plus mirror therapy, iTBS to the ipsilesional primary motor cortex plus sham mirror therapy |
| Mirror TherapyParticipants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. | Behavioural | Sham iTBS over the ipsilesional primary motor cortex plus mirror therapy, iTBS over the ipsilesional primary motor cortex plus mirror therapy |
| Sham intermittent theta burst stimulationiTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. However, a sham coil will be used, which is not associated with any stimulation effect on the brain. | Device | Sham iTBS over the ipsilesional primary motor cortex plus mirror therapy |
| Sham mirror TherapyIn sham mirror therapy, the mirror will be covered. Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to move the non-affected hand. The participants cannot receive mirror visual feedback of the paretic upper extremity movement during the therapy. Same as mirror therapy, the movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes. | Behavioural | iTBS to the ipsilesional primary motor cortex plus sham mirror therapy |
Primary outcome
Fugl-Meyer assessment (FMA)
Time frame: Baseline
A stroke-specific, performance-based impairment index
Fugl-Meyer assessment (FMA)
Time frame: 1 day
A stroke-specific, performance-based impairment index
Fugl-Meyer assessment (FMA)
Time frame: 2 weeks
A stroke-specific, performance-based impairment index
Fugl-Meyer assessment (FMA)
Time frame: 1-month after the completion of the intervention
A stroke-specific, performance-based impairment index
Action Research Arm Test (ARAT)
Time frame: Baseline (immediately before the first session)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Action Research Arm Test (ARAT)
Time frame: 1 day
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Action Research Arm Test (ARAT)
Time frame: 2 weeks
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Action Research Arm Test (ARAT)
Time frame: 1-month after the completion of the intervention
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
16 secondary outcomes
EEG rhythm power
Time frame: Baseline (immediately before the first session)
EEG rhythm power
Time frame: 1 day
EEG rhythm power
Time frame: 2 weeks
EEG rhythm power
Time frame: 1-month after the completion of the intervention
Motor-evoked Potential (MEP)
Time frame: Baseline (immediately before the first session)
Motor-evoked Potential (MEP)
Time frame: 1 day
Motor-evoked Potential (MEP)
Time frame: 2 weeks
Motor-evoked Potential (MEP)
Time frame: 1-month after the completion of the intervention
Cortical silent period
Time frame: Baseline (immediately before the first session)
Cortical silent period
Time frame: 1 day
Cortical silent period
Time frame: 2 weeks
Cortical silent period
Time frame: 1-month after the completion of the intervention
Ipsilateral silent period
Time frame: Baseline (immediately before the first session)
Ipsilateral silent period
Time frame: 1 day
Ipsilateral silent period
Time frame: 2 weeks
Ipsilateral silent period
Time frame: 1-month after the completion of the intervention
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 2 Feb 2023.
- 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.
Kenneth Nai Kuen FONG, PHD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst stimulation and Mirror Therapy in people with Stroke and Hemiplegia, 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 8 inclusion and 7 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 2 Feb 2023. 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?
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?
Fugl-Meyer assessment (FMA) (time frame: Baseline). The study lists 8 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 2 Feb 2023.