The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study
NCT ID: NCT06241508
Last Updated: 2025-06-13
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-02-15
2025-05-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Low-intensity priming intermittent theta burst stimulation
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.
Transcranial magnetic stimulation
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.
Conventional intensity priming intermittent theta burst stimulation
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.
Transcranial magnetic stimulation
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.
Standard, nonpriming intermittent theta burst stimulation
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.
Transcranial magnetic stimulation
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.
Interventions
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Transcranial magnetic stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* (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.
Exclusion Criteria
* (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.
18 Years
80 Years
ALL
Yes
Sponsors
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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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Other Identifiers
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HSEARS20231104003
Identifier Type: -
Identifier Source: org_study_id
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