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

NCT06849505 | Recruiting

• 1 other identifier: CHEC2025-055
• Study Type: interventional
• Target: 15
• 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 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.

Conditions

Upper Extremity Parasis; Stroke

Keywords

stroke; individualized; TMS; motor dysfunction; online

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 60 after 2-week intervention

Secondary Outcomes (4)

• Modified Barthel Index (MBI)

  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)

  Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention

• Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)

  Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 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)

online rTMS

EXPERIMENTAL

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.

Device: online rTMS

offline rTMS

ACTIVE COMPARATOR

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.

Device: offline rTMS

sham rTMS

SHAM COMPARATOR

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.

Device: sham rTMS

Interventions

online rTMS DEVICE

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

online rTMS

offline rTMS DEVICE

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

offline rTMS

sham rTMS DEVICE

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

sham rTMS

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.
• 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

• First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University: lead
• shanghai center for brain science and brain-inspired technology: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200021, China

RECRUITING

MeSH Terms

Conditions

Stroke; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ying Wang

CONTACT

+86-15221359901; 1327907674@qq.com

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: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: July 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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)