NCT06241508

The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-03-10
• Completion: 2025-05-30
• First posted: 2024-02-05
• Last updated: 2025-06-13

Locations

1 site across 1 country: Hong Kong