Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke: a Randomized Controlled Trial
NCT Number: NCT06509789
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
Sponsor: The Hong Kong Polytechnic University
Collaborators: Tung Wah Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-09-30
Locations: Jack Jiaqi Zhang, Hong Kong, 000000, Hong Kong

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.

Primary Outcome Measures: The Fugl-Meyer Assessment-Upper Extremity Scores, 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, Baseline|The Fugl-Meyer Assessment-Upper Extremity Scores, 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, At 3 weeks|The Fugl-Meyer Assessment-Upper Extremity Scores, 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, At one-month
Secondary Outcome Measures: P30 amplitude in the TMS-evoked potential, 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., Baseline|P30 amplitude in the TMS-evoked potential, 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., At 3 weeks|P30 amplitude in the TMS-evoked potential, 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., At one-month