DOI: 10.5281/zenodo.17345584
title: rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients

description: 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 Does rTMS combined with motor training improve motor rehabilitation in patients?

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 ?

Researchers will compare online rTMS to offline and sham stimulation in stroke patients to see if online rTMS works to alleviate motor dysfunction in multicenter multicenter, blinded and controlled trial. Participants will:

1 randomized to one group(online, offline 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.







Detailed Description







In this study, 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%~80% of TMS output.Patients were stimulated over 2 week period, 4 sessions of tasks were performed everyday. The patient will undergo a 2-week (10-day) stimulation protocol, with fourty tasks performed daily. This includes one session of 10 baseline tasks measurement and three sessions of 5 Hz rTMS synchronized with 10 motor tasks. rTMS will be applied to the ipsilesional motor cortex.

Arms and Interventions




Arms
Interventions






Experimental : Online stimulation5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.



Online stimulation5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.

 






Active Comparator : Offline stimulationAfter 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.



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

 






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



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





Primary Outcome Measures

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).


Secondary Outcome Measures

2. Mean Change in ARAT score from Baseline



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.


3. Mean Change in WMFT score from Baseline



The WMFT is used to assess the upper limb motor function of patients and serves as an effective supplement to the FMA-UE. By timing single-joint movements, multi-joint movements, and functional activities, as well as evaluating movement quality and speed, it can quantitatively assess the upper limb motor ability of stroke patients. It is more sensitive to patients with mild to moderate stroke, and its grading is relatively detailed, which can sensitively reflect the subtle changes in patients' motor function during evaluation.

The WMFT consists of 15 items, among which items 1-6 are simple joint movements, and items 7-15 are complex functional actions. This scale can not only evaluate impairments but also assess the effect of training on disabilities. The WMFT has good validity and reliability and can be used to evaluate the upper limb function of stroke patients.


4. Mean Change in MBI score from Baseline



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).


5. Mean Change in PSQI score from Baseline



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.


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



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.


7. The average completion time for baseline tasks



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.


The way of sharing IPD

Method of obtaining the raw data: If there are reasonable requests, the related raw data to support the research results can be obtained from the corresponding authors or the first authors. 

Dataset and code description

To be uploaded...