Transcranial Magnetic Stimulation Synchronized with Motor Task Training for Post-Stroke Rehabilitation
NCT ID: NCT06849505
Last Updated: 2025-02-27
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
15 participants
INTERVENTIONAL
2024-07-02
2025-06-30
Brief Summary
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Does rTMS synchronized with motor training improve motor rehabilitation in patients with the ability to induce motor evoked potentials(MEPs)？ Dose individualized rTMS synchronized with motor training improve motor rehabilitation in patients without the ability to induce MEPs? Researchers will compare online rTMS to offline and sham stimulation in patients with MEPs to see if online rTMS works to alleviate motor dysfunction in preliminary trials. And compare individualized online rTMS to non-individualized online rTMS and sham in patients without MEPs to see if individualized online rTMS works to alleviate motor dysfunction in Randomized, double-blinded, and controlled trials.
Participants will:
randomized to one group acoording to the MEP condition of each person; receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks; receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment; 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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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online rTMS
In the online stimulation group, the TMS treatment will continuously adjust the TMS parameters according to the baseline data and the data changes during the treatment to achieve personalized intervention. When patients receive TMS treatment, it is combined with upper limb movement tasks. When the task starts autonomously, TMS stimulation is triggered through electromyographic feedback. When the task stops or is completed, the TMS stimulation also stops immediately according to the electromyographic feedback, achieving real - time effects.
online rTMS
5 Hz rTMS is applied to the MRI-localized hotspot on the affected hemisphere when the patients are performing motor tasks
offline rTMS
For the offline stimulation group, TMS treatment will be carried out before the task starts. After the stimulation ends, the subjects will then complete the task.
offline rTMS
The patients perform motor tasks after 5 Hz rTMS applied to the MRI-guided hotspot on the affected hemisphere
sham rTMS
Patients in the sham group also receive sham stimulation treatment combined with specific tasks, which is the same as the online stimulation group, except that the TMS stimulation is sham stimulation.
sham rTMS
Sham rTMS is applied to the M1 on the affected hemisphere when the patients are performing motor tasks.
Interventions
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online rTMS
5 Hz rTMS is applied to the MRI-localized hotspot on the affected hemisphere when the patients are performing motor tasks
offline rTMS
The patients perform motor tasks after 5 Hz rTMS applied to the MRI-guided hotspot on the affected hemisphere
sham rTMS
Sham rTMS is applied to the M1 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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shanghai center for brain science and brain-inspired technology
UNKNOWN
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
OTHER
Responsible Party
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Xiaonan Huang
Principal Investigator
Locations
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First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEC2025-055
Identifier Type: -
Identifier Source: org_study_id
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