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Priming Theta Burst Stimulation for Stroke: A Study of Intensity

RecruitingNAAges 18 Years - 80 YearsAllThe Hong Kong Polytechnic University
NCT06509789 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 assig

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📋 Eligibility rules (as published)
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).
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What it tests

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

1 site
Jack Jiaqi Zhang
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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