Using rTMS to treat movement disorders in patients with brain hemorrhage
Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH): A Randomized, Blinded, Sham-controlled Trial.
This study is testing if a brain stimulation treatment called rTMS can help improve movement problems in people aged 45 to 65 who have had a brain hemorrhage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT05920473 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) for treating movement disorders in patients who have experienced an intracerebral hemorrhage (ICH). Participants aged 45 to 65, with severe motor impairment following ICH, will be randomly assigned to receive either real rTMS treatment or a sham treatment. The study will assess clinical outcomes such as motor function and daily living activities over a period of six months. The goal is to determine if rTMS can improve motor function by promoting remodeling of the brain's motor systems.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 65 who have experienced an ICH and have severe to moderately severe motor functional impairment.
Not a fit: Patients with movement disorders due to causes other than ICH or those with a history of epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motor function and quality of life for patients recovering from intracerebral hemorrhage.
How similar studies have performed: Previous studies have shown promise for rTMS in improving motor function in stroke patients, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants between the ages of 45 and 65 years old. 2. More than 1 month and less than 3 months after ICH 3. With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to 55. 4. Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans. 5. Participants should have a stable level of consciousness, with a score of 0 to 1 on the level of consciousness, level of consciousness questions, and level of consciousness instructions of the National Institutes of Health Stroke Scale (NIHSS), along with stable vital signs. 6. Underwent surgical treatment for ICH within 2 weeks after the event, utilizing either craniotomy or endoscopic hematoma evacuation, with an evacuation rate of at least 80%. 7. Signed the informed consent. Exclusion Criteria: 1. With a history of epilepsy. 2. With movement disorders resulting from causes other than basal ganglia hemorrhage. 3. With severe general impairment or coexisting medical conditions. 4. With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below 21. 5. With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.
Where this trial is running
Beijing, Beijing and 2 other locations
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
- Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids — Beijing, China (Recruiting)
- Shenzhen Qianhai Shekou Free Trade Zone Hospital — Shenzhen, China (Recruiting)
Study contacts
- Principal investigator: Yong Cao, M.D. — Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
- Study coordinator: Yong Cao, M.D.
- Email: caoyong@bjtth.org
- Phone: +86(010)59976510
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.