Low-intensity brain stimulation to improve motor function after stroke
The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study
This study is testing if a new type of gentle brain stimulation can help stroke patients improve their movement better than standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06241508 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-intensity continuous theta burst stimulation (cTBS) combined with intermittent theta burst stimulation (iTBS) on motor recovery in stroke patients. A total of 30 participants, including 15 stroke patients and 15 healthy adults, will undergo three different stimulation protocols to assess changes in cortical activity and motor behavior. The goal is to determine if the low-intensity priming stimulation yields better outcomes than conventional methods. The findings aim to enhance future clinical trials focused on optimizing brain stimulation techniques for poststroke recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have experienced a stroke at least six months prior and have some residual upper limb function.
Not a fit: Patients with severe cognitive impairments or other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor recovery in stroke patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise with theta burst stimulation techniques, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) have a diagnosis of monohemispheric ischemic or hemorrhagic stroke, with time after stroke onset≥6 months; * (2) aged between 18 and 80 years old; * (3) with residual upper limb functions from 2-6 levels in the Functional Test for the Hemiplegic Upper Extremity, i.e., moderately impaired overall upper extremity functions. * (4) able to give informed written consent to participate in the study. Exclusion Criteria: * (1) any contraindications to TMS (screened by the safety checklist by Rossi \[12\]); - * (2) any concomitant neurological disease; * (3) any sign of moderate-to-severe cognitive problems, i.e., Montreal cognitive assessment (MoCA)\<19/30 * (4) Modified Ashworth score\>2 in hand, wrist or elbow extensor muscle in the hemiparetic upper extremity. In addition, a group of age-matched, right-hand dominant healthy adults without any known neurological diseases will be enrolled. Healthy adults with any contraindications to TMS will be excluded.
Where this trial is running
Hong Kong
- Jack Jiaqi Zhang — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Jack Zhang, PhD
- Email: jack-jq.zhang@connect.polyu.hk
- Phone: 27666696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.