rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients

NCT06752499 | Completed

• 1 other identifier: 2022361
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trials is to investigate the effectiveness of 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 rTMS combined with motor training improve motor rehabilitation in patients？
2. 2.Does repetitive transcranial magnetic stimulation (rTMS) 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(online, offline 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

Stroke; Upper Extremity Paresis

Keywords

Repetitive Transcranial Magnetic Stimulation; Upper Limb Motor Dysfunction; online; motor task training; individualized; Motor evoked potentials

Outcome Measures

Primary Outcomes (1)

• Mean Change in FM-UE From Baseline

  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). FM-UE scale was assessed by site raters who were masked to the intervention).

  Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)

Secondary Outcomes (8)

• Mean Change in ARAT score from Baseline

  Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)

• Mean Change in WMFT score from Baseline

  Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)

• Mean Change in MBI score from Baseline

  Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)

• Mean Change in PSQI score from Baseline

  Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)

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

  Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15); Follow-up 1 (day 45); Follow-up 2 (day105)

Study Arms (3)

Online stimulation

EXPERIMENTAL

5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.

Device: Online stimulation

Offline stimulation

ACTIVE COMPARATOR

After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.

Device: Offline stimulation

Sham stimulation

SHAM COMPARATOR

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

Device: Sham stimulation

Interventions

Online stimulation DEVICE

5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.

Online stimulation

Offline stimulation DEVICE

After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.

Offline stimulation

Sham stimulation DEVICE

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

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.
• 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

• Shanghai Sunshine Rehabilitation Center: collaborator
• Ruijin Hospital: lead
• Changhai Hospital: collaborator
• shanghai center for brain science and brain-inspired technology: collaborator

Study Sites (3)

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

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Yang Zhi Rehabilitation Hospital

Shanghai, Songjiang, China

Location

Changhai Hospital

Shanghai, Yangpu, China

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: December 27, 2024
• First Posted: December 30, 2024
• Study Start: February 20, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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 (3)