Clinical trial NCT06241508: The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study
Official title: The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
transcranial magnetic stimulation
theta burst stimulation
neuroplasticity
motor learning
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: The isometric force control task
timeFrame: Baseline
measure: The isometric force control task
timeFrame: 15-min after completion of stimulation sessions
measure: Transcranial magnetic stimulation-evoked potential
timeFrame: Baseline
measure: Transcranial magnetic stimulation-evoked potential
timeFrame: 5-min after completion of stimulation sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Jack Jiaqi Zhang
Study officials:
References: