rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
NCT ID: NCT06752499
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-02-20
2025-12-31
Brief Summary
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1. Does rTMS combined with motor training improve motor rehabilitation in patients？
2. Does repetitive transcranial magnetic stimulation (rTMS) combined with motor training enhance the upper limb motor rehabilitation ability in stroke patients by strengthening the functional coupling of the motor circuit to achieve functional reorganization of the brain network ?
Researchers will compare online rTMS to offline and sham stimulation in stroke patients to see if online rTMS works to alleviate motor dysfunction in multicenter multicenter, blinded and controlled trial.
Participants will:
1. randomized to one group(online, offline or sham);
2. receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
3. receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
4. conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
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Detailed Description
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Patients were stimulated over 2 week period, 4 sessions of tasks were performed everyday. The patient will undergo a 2-week (10-day) stimulation protocol, with fourty tasks performed daily. This includes one session of 10 baseline tasks measurement and three sessions of 5 Hz rTMS synchronized with 10 motor tasks. rTMS will be applied to the ipsilesional motor cortex.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Online stimulation
5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Online stimulation
5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Offline stimulation
After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
Offline stimulation
After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
Sham stimulation
Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Sham stimulation
Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Interventions
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Online stimulation
5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Offline stimulation
After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
Sham stimulation
Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Eligibility Criteria
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Inclusion Criteria
2. The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
3. The age is between 20 and 80 years old.
4. The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
5. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
6. There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures).
7. The patient or guardian agrees to sign the informed consent form.
Exclusion Criteria
2. Those with a history of aphasia, severe cognitive impairment or mental illness;
3. Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
4. Those with severe visual or hearing impairments, unable to communicate normally;
5. People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
20 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Shanghai Yangzhi Rehabilitation Hospital
UNKNOWN
shanghai center for brain science and brain-inspired technology
UNKNOWN
Ruijin Hospital
OTHER
Responsible Party
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Qing Xie, PhD
Professor
Locations
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Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine
Shanghai, Shanghai Municipality, China
Shanghai Yang Zhi Rehabilitation Hospital
Shanghai, Songjiang, China
Changhai Hospital
Shanghai, Yangpu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022361
Identifier Type: -
Identifier Source: org_study_id
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