Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).
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.
1 other identifier
interventional
130
1 country
3
Brief Summary
This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 27, 2023
June 1, 2023
1.5 years
June 4, 2023
June 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fugl-Meyer Assessment (FMA)
Motor function was evaluated using the FMA, a scale ranging from 0 to 100 that measures movement ability. Higher scores reflect better motor function. The outcome measure assesses the change in the FMA score at 6 months compared to baseline.
Month 6
Secondary Outcomes (6)
Change in Fugl-Meyer Assessment (FMA)
Day 1, Month 1, Month 3
Fugl-Meyer Assessment (FMA) Response
baseline, Day 1, Month 1, Month 3, Month 6
Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)
Day 1, Month 1, Month 3, Month 6
Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)
Day 1, Month 1, Month 3, Month 6
Change in Barthel Index (BI) score
Day 1, Month 1, Month 3, Month 6
- +1 more secondary outcomes
Other Outcomes (3)
Changes in the structural brain network connectivity
Month 6
Changes in the functional brain network connectivity
Month 6
Changes in the resting state brain network connectivity
Month 6
Study Arms (2)
rTMS intervention group
EXPERIMENTALParticipants 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.
Sham group
SHAM COMPARATORPatients 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.
Interventions
The study will involve the utilization of the Magstim Rapid 2 magnetic stimulation device to administer rTMS treatment to the participants. The coil will be positioned tangentially on the scalp, specifically targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. During the stimulation protocol, a 10-Hz stimulation will be applied for 2 seconds, followed by a 10-second rest period. This cycle will be repeated 50 times. The treatment will be administered once daily, from Monday to Friday, for a continuous period of two weeks.
In the sham group, patients received sham stimulation using the 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 further reduce the potential impact of rTMS.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Beijing, China
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Cao, M.D.
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
June 4, 2023
First Posted
June 27, 2023
Study Start
July 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 27, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share