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

NCT07049211 | Not Yet Recruiting

• 1 other identifier: 2025296
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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. 1.Does individualized rTMS precise target combined with motor training improve upper limb motor rehabilitation in patients？
2. 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 ?
3. 3.randomized to one group(individualized online, non-individualized online or sham);
4. 4.receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
5. 5.receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
6. 6.conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.

Conditions

Upper Extremity Dysfunction After the Stroke

Keywords

repetitive transcranial magnetic stimulaiton; stroke; online; individualized; upper limb motor dysfunction

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

  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).

  Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

Secondary Outcomes (5)

• Action Research Arm Test (ARAT)

  Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week 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 Pittsburgh Sleep Quality Index (PSQI)

  Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

• 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

• 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

Study Arms (3)

Individualized online stimulation

EXPERIMENTAL

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 paired 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.

Device: Individualized online stimulation

Non-individualized online stimulation

ACTIVE COMPARATOR

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.

Device: Non-individualized online stimulation

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham stimulation

Interventions

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.

Individualized online stimulation

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.

Non-individualized online stimulation

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.

Sham stimulation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• shanghai center for brain science and brain-inspired technology: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (26)

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Related Links

• The URL is the data sharing website of this study, which briefly describes the protocol and objectives of the research.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wang, PhD

  shanghai center for brain science and brain-inspired technology

  STUDY DIRECTOR

Central Study Contacts

Yang LIU, Master of Medicine

CONTACT

+8615821650228; ly12446@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 3, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): January 20, 2028
• Study Completion (Estimated): May 20, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Authorized professional researchers, including but not limited to researchers engaged in neuroscience research who have obtained data access permission from their affiliated institutions, and clinical doctors from other medical institutions that have a cooperative relationship with this study and have signed data confidentiality agreements. They can access the detailed clinical medical histories of the participants, including past disease histories and treatment process records; neurological function assessment scale data; as well as imaging data collected during the study, such as brain magnetic resonance imaging (MRI) results. However, sensitive information related to participants' privacy, such as names, ID numbers, and contact information, will be strictly anonymized to ensure that such information cannot be obtained. They can contact the corresponding author or the first author via email.

Locations

CN (1)