Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke: a Randomized Controlled Trial
- Conditions
- Stroke
- Interventions
- Device: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
- Registration Number
- NCT06509789
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
Objectives: To compare the effects of low intensity priming intermittent theta burst stimulation (iTBS) with those derived from conventional intensity priming iTBS, nonpriming iTBS, and sham stimulation in terms of improving hemiparetic upper limb motor functionality and modulating cortical excitation/inhibition in patients with stroke.
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 100 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.
- Detailed Description
Objectives: To compare the effects of low intensity priming intermittent theta burst stimulation (iTBS) with those derived from conventional intensity priming iTBS, nonpriming iTBS, and sham stimulation in terms of improving hemiparetic upper limb motor functionality and modulating cortical excitation/inhibition in patients with stroke.
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 100 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low intensity priming intermittent theta burst stimulation (iTBS) Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol 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. Standard priming intermittent theta burst stimulation (iTBS) Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol 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. Nonpriming intermittent theta burst stimulation (iTBS) Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol 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. Sham stimulation Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol 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).
- Primary Outcome Measures
Name Time Method The Fugl-Meyer Assessment-Upper Extremity Scores At one-month The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb
- Secondary Outcome Measures
Name Time Method P30 amplitude in the TMS-evoked potential At one-month TMS-evoked potential is a time-locked signal elicited by single TMS pulses delivered to the cortex. P30 means the positive peak appeared at 30 ms after stimulation. The amplitude of P30 is correlated with cortical excitability mediated by excitatory interneurons.
Trial Locations
- Locations (1)
Jack Jiaqi Zhang
🇭🇰Hong Kong, Hong Kong