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NCT Number: NCT07049211

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

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.

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Key information

Conditions

Upper Extremity Dysfunction After the Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine

Shanghai, Shanghai Municipality, 200025, China

Location contact

Yifeng WANG

CONTACT

[email protected]

+8602154661789

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
  • Those with a history of aphasia, severe cognitive impairment or mental illness;
  • Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
  • Those with severe visual or hearing impairments, unable to communicate normally;
  • People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.

Treatment and study plan

Individualized online stimulation

Device

The individualized online stimulation group will calculate precise targets based on the collected multimodal MRI (structural images, resting-state/task-state functional images, and diffusion tensor imaging), plan the coil position and placement angle of TMS through electric field simulation, and achieve individualized intervention. At the same time, when patients receive TMS treatment, they are matched with specific upper limb motor tasks. When the task starts autonomously, TMS stimulation is triggered by acceleration-EMG feedback. When the task stops or is completed, TMS stimulation also stops immediately according to the acceleration-EMG feedback to achieve real-time effects.

Non-individualized online stimulation

Device

In the non-individualized online stimulation group, patients receive TMS treatment synchronized with task training. However, the targeting uses traditional positioning methods, i.e., determining the target with a positioning cap instead of precise target localization.

Sham stimulation

Device

In the individualized online sham stimulation group, patients receive TMS treatment combined with specific tasks. The stimulation targets are the same as those in the online stimulation group, all determined by precise target localization, except that a sham stimulation coil is used for TMS stimulation.

Primary outcomes

  1. Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

    Time frame: 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 outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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.

  2. Modified Barthel Index (MBI)

    Time frame: 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).

  3. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  4. Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)

    Time frame: 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.

  5. The average completion time for baseline tasks

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang LIU, Master of Medicine

CONTACT

[email protected]

+8615821650228

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • shanghai center for brain science and brain-inspired technology

Registry information

Official study title

Individualized Closed-Loop Neuromodulation With Repetitive Transcranial Magnetic Stimulation Synchronized Task Training for Upper Limb Motor Dysfunction in Stroke Patients

Acronym: rTMS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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