Individualized rTMS Synchronized Task Training for Closed-loop Neuromodulation of Post-stroke Motor Dysfunction

Not Applicable

Not yet recruiting

• Conditions: Upper Extremity Dysfunction After the Stroke

• Registration Number: NCT07049211
• Lead Sponsor: Ruijin Hospital

Brief Summary

The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of online rTMS intervention methods. The main questions it aims to answer are:

1. Does individualized rTMS precise target combined with motor training improve upper limb motor rehabilitation in patients？

2. Does individualized rTMS precise target 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 individualized online rTMS to non-individualized online and individualized sham stimulation in stroke patients to see if individualized online rTMS works to alleviate motor dysfunction in this randomized，sham-controlled, double-blind trial.

Participants will:

1. randomized to one group(individualized online, non-individualized online 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Study Start: 2025-07-20
• Primary Completion: 2028-01-20
• Study Completion: 2028-05-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
2. The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
3. Motor evoked potentials(MEPs) of First Dorsal Interosseous Muscle（FDI）or Abductor Pollicis Brevis Muscle (APB) is negative in ipsilesional hemisphere.
4. The age is between 20 and 80 years old.
5. The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
6. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
7. 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).
8. The patient or guardian agrees to sign the informed consent form.

Exclusion Criteria

1. Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)	Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance).

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention	The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. The ARAT was originally described by Lyle in 1981 as a modified version of the Upper Extremity Function Test and was used to examine upper limb functional recovery post damage to the cortex.
The Pittsburgh Sleep Quality Index (PSQI)	Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention	The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. The PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. It allows researchers and healthcare providers alike to obtain a comprehensive understanding of an individual's sleep patterns and disturbances and inform treatment decisions and interventions for sleep disorders.
Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)	Baseline; Day 6 during 2-week intervention; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention	Resting motor threshold is an objective measure of cortical excitability. Numerous studies indicate that the success of motor recovery after stroke is significantly determined by the direction and extent of cortical excitability changes.
The average completion time for baseline tasks	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day7, Day 8, Day 9, Day 10 during TMS intervention	The average completion time for baseline tasks refers to the time (seconds) taken by the patient to complete the baseline motor task before each intervention.
Modified Barthel Index (MBI)	Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention	The Barthel Index for activities of daily living was introduced in 1965 by Barthel and Mahoney to be used in the assessment of the degree of assistance required by patients with stroke (other neuromuscular or musculoskeletal disorders or oncology patients) with regards to 10 items of mobility and self-care (ADL).

Trial Locations

Locations (1)

Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine; 🇨🇳 Shanghai, Shanghai, China