Priming theta burst stimulation intensity for improving arm recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will enroll 108 adults with chronic unilateral ischemic stroke and moderate-to-severe upper‑limb impairment. Participants are randomly assigned to one of four groups (low‑intensity priming iTBS, conventional‑intensity priming iTBS, nonpriming iTBS, or double‑sham) and receive three stimulation sessions per week for four weeks followed by 60 minutes of standardized motor training each session. Outcomes include clinical upper‑limb motor tests and measures of cortical excitation/inhibition using TMS and EEG, with MRI used to confirm lesion location. The study compares a 55% RMT priming protocol plus 70% RMT iTBS against other priming intensities and sham to see which produces the best motor and neurophysiologic changes.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Unilateral upper limb motor dysfunction caused by ischemic or hemorrhagic stroke, with stroke onset≥6 months. Diagnosis will be verified using discharge summary and radiological reports issued by Hospital Authority. Qualifying participants will undergo structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience (UBSN) at PolyU to further confirm their lesion location in the period of experimental participation.
2. Age between 18 and 80 years.
3. Residual upper limb functions between levels 2-7 in the FTHUE, indicating moderately-to-severely impaired upper limb motor functions.
4. Capable of providing informed written consent. Exclusion Criteria

Patients who meet any of the following criteria will be excluded:

1. any contraindications to TMS (screened by the safety checklist by Rossi(33)) and/or MRI (screened by the MRI safety checklist offered by UBSN \[see supplement\]).
2. Diagnosed with any concomitant neurological disease other than stroke.
3. signs of cognitive impairment, with a Montreal cognitive assessment score\<21/22 out of 30 (34).
4. Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score \> 2 (35).

Where it's running

• Jack Jiaqi Zhang
  Hong Kong, Hong Kong, Hong Kong Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.