Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, theta burst stimulation, upper limb, metaplasticity, priming
Eligibility Criteria
Inclusion Criteria:
- with a diagnosis of a unilateral ischemic or hemorrhagic stroke;
- with stroke onset more than 6 months;
- from 18 to 75 years old;
- with mild to moderate impairment of upper limb functions due to stroke, measured using the Hong Kong Version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) from level 2 to level 7;
- be able to understand verbal instruction and follow one-step commands;
- be able to give informed consent to participate;
Exclusion Criteria:
- any contraindications to rTMS/TBS, such as unstable medical condition, history of epileptic seizures, metal implants in vivo (eg, pacemaker, artificial cochlear, and implant brain stimulator), and a history of receiving craniotomy;
- previous diagnosis of any neurological disease excluding stroke;
- presence of any sign of cognitive problems (Abbreviated mental test Hong Kong version < 6/10);
- patients with extreme spasticity in any hemiplegic upper limb joint (Modified Ashworth score > 2) or severe pain that hinder the upper limb motor training;
- with other notable impairment of the upper limb affected by stroke, eg, recent fracture, severe osteoarthritis, congenital upper limb deformity
- any sign of anxiety or depression, as assessed by the Hospital Anxiety and Depression Scale.
- concurrent participation in an upper limb rehabilitation program or a medicine trial.
Sites / Locations
- The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Sham Comparator
cTBS + iTBS, in addition to robot-assisted training
Sham cTBS + iTBS, in addition to robot-assisted training
Sham cTBS + sham iTBS, in addition to robot-assisted training
Participants will receive 10-session intervention of priming iTBS protocol (cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session.
Participants will receive 10-session intervention of non-primed, standard iTBS (sham cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session.
Participants will receive 10-session intervention of sham stimulation (sham cTBS followed by sham iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session.