Priming Theta Burst Stimulation for Stroke: A Study of Intensity
NCT ID: NCT06509789
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-01
2027-09-30
Brief Summary
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Hypothesis to be tested: We hypothesize that low intensity priming iTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in enhanced cortical excitation and reduced cortical inhibition, thereby enabling superior upper limb motor recovery in patients with stroke.
Design and subjects: A randomized controlled trial involving 108 patients with chronic stroke.
Study instruments: Transcranial magnetic stimulation (TMS) and electroencephalography (EEG).
Interventions: Participants will be randomly assigned into one of the following four groups: (1) low intensity priming iTBS (55% resting motor threshold \[RMT\] continuous theta burst stimulation \[cTBS\]+70% RMT iTBS); (2) conventional intensity priming iTBS (70% RMT cTBS+70% RMT iTBS); (3) nonpriming iTBS (sham cTBS+70% RMT iTBS); and (4) sham stimulation (sham cTBS+sham iTBS). All participants will receive 60-minute standard motor training after completion of the stimulation program. The intervention will last four weeks, with three sessions per week.
Main outcome measures: Upper limb motor tests and levels of cortical excitation/inhibition measured by TMS-evoked EEG potentials.
Data analysis: Analysis of variance (ANOVA). Expected results: The low intensity priming iTBS protocol will be the most efficacious protocol for enhancing cortical excitation and reducing cortical inhibition in post-stroke patients and will thereby produce superior outcomes with regard to upper limb motor functionality.
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Detailed Description
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Hypothesis to be tested: We hypothesize that low intensity priming iTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in enhanced cortical excitation and reduced cortical inhibition, thereby enabling superior upper limb motor recovery in patients with stroke.
Design and subjects: A randomized controlled trial involving 108 patients with chronic stroke.
Study instruments: Transcranial magnetic stimulation (TMS) and electroencephalography (EEG).
Interventions: Participants will be randomly assigned into one of the following four groups: (1) low intensity priming iTBS (55% resting motor threshold \[RMT\] continuous theta burst stimulation \[cTBS\]+70% RMT iTBS); (2) conventional intensity priming iTBS (70% RMT cTBS+70% RMT iTBS); (3) nonpriming iTBS (sham cTBS+70% RMT iTBS); and (4) sham stimulation (sham cTBS+sham iTBS). All participants will receive 60-minute standard motor training after completion of the stimulation program. The intervention will last four weeks, with three sessions per week.
Main outcome measures: Upper limb motor tests and levels of cortical excitation/inhibition measured by TMS-evoked EEG potentials.
Data analysis: Analysis of variance (ANOVA). Expected results: The low intensity priming iTBS protocol will be the most efficacious protocol for enhancing cortical excitation and reducing cortical inhibition in post-stroke patients and will thereby produce superior outcomes with regard to upper limb motor functionality.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low intensity priming intermittent theta burst stimulation (iTBS)
Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Low intensity priming iTBS consists of a session of 55% RMT cTBS, followed by 70% RMT iTBS.
Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.
Standard priming intermittent theta burst stimulation (iTBS)
Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Standard priming iTBS consists of a session of 70% RMT cTBS, followed by 70% RMT iTBS.
Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.
Nonpriming intermittent theta burst stimulation (iTBS)
Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Nonpriming iTBS consists of a session of 20% RMT cTBS (sham), followed by 70% RMT iTBS.
Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.
Sham stimulation
Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Sham stimulation consists of a session of 20% RMT cTBS (sham), followed by 20% RMT iTBS (sham).
Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.
Interventions
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Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 80 years.
3. Residual upper limb functions between levels 2-6 in the FTHUE, indicating moderately-to-severely impaired upper limb motor functions.
Exclusion Criteria
1. any contraindications to TMS (screened by the safety checklist by Rossi(33)) and/or MRI (screened by the MRI safety checklist offered by UBSN \[see supplement\]).
2. Diagnosed with any concomitant neurological disease other than stroke.
3. signs of cognitive impairment, with a Montreal cognitive assessment score\<21/22 out of 30 (34).
4. Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score \> 2 (35).
18 Years
75 Years
ALL
No
Sponsors
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Tung Wah Hospital
OTHER
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Locations
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Jack Jiaqi Zhang
Hong Kong, Hong Kong, Hong Kong
Countries
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Facility Contacts
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Other Identifiers
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HSEARS20240229001
Identifier Type: -
Identifier Source: org_study_id
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