Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).
Intracerebral Hemorrhage
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, Movement Disorders, Repetitive Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria: Participants between the ages of 45 and 65 years old. More than 1 month and less than 3 months after ICH With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to 55. Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans. 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. 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%. Signed the informed consent. Exclusion Criteria: With a history of epilepsy. With movement disorders resulting from causes other than basal ganglia hemorrhage. With severe general impairment or coexisting medical conditions. With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below 21. With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
- Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical AidsRecruiting
- Shenzhen Qianhai Shekou Free Trade Zone HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
rTMS intervention group
Sham group
Participants will undergo rTMS treatment using the Magstim Rapid 2 magnetic stimulation device. The coil was placed positioned tangentially on the scalp, targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. The stimulation protocol will involve 10-Hz stimulation for 2 seconds, followed by a followed by a 10-second rest, which was repeated 50 times. Patients will receive treatment once a day, five days a week (Monday to Friday), for a total of two consecutive weeks.
Patients in the sham group underwent sham stimulation using the Magstim Rapid 2 magnetic stimulation device with the same protocol. The coil was positioned to target the same hot spot, with an angulation parallel to the gyrus to the gyrus in order to additionally minimize the rTMS effect.