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NCT Number: NCT06849505

Transcranial Magnetic Stimulation Synchronized with Motor Task Training for Post-Stroke Rehabilitation

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 individualized online rTMS intervention methods. The main questions it aims to answer are:

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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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

Shanghai, Shanghai Municipality, 200021, China

Location status: Recruiting

Location contact

Jia Min Li

CONTACT

[email protected]

+86-13917245215

About this study

In our experiment, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70% of TMS output.

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.
  • 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

online rTMS

Device

5 Hz rTMS is applied to the MRI-localized hotspot on the affected hemisphere when the patients are performing motor tasks

offline rTMS

Device

The patients perform motor tasks after 5 Hz rTMS applied to the MRI-guided hotspot on the affected hemisphere

sham rTMS

Device

Sham rTMS is applied to the M1 on the affected hemisphere when the patients are performing motor tasks.

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 60 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. Modified Barthel Index (MBI)

    Time frame: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 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).

  2. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 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.

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

    Time frame: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

Other

Collaborators

  • shanghai center for brain science and brain-inspired technology

Registry information

Official study title

Closed - Loop Neuromodulation of Post - Stroke Motor Dysfunction by Transcranial Magnetic Stimulation Synchronized with Specific Motor Task Training

Acronym: TMS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Feb 27, 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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