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RECRUITING
NCT06509789
NA

Priming Theta Burst Stimulation for Stroke: A Study of Intensity

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

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 108 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.

Official title: Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-01

Completion Date

2027-09-30

Last Updated

2025-07-24

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol

This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.

Locations (1)

Jack Jiaqi Zhang

Hong Kong, Hong Kong, Hong Kong