Individualized rTMS Based on fNIRS to Spasticity

Study Overview
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Brief Summary
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Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity.

Official Title
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Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke

Conditions
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Stroke, Spasticity, Muscle, Rehabilitation

Intervention / Treatment
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* Procedure: individual rTMS based on fNIRS
* Procedure: Traditional rTMS strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-79 years; Patients with first-onset stroke within 1 to 3 months after onset; Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment; The patient or its authorized agent signs the informed consent form. Exclusion Criteria: Previous seizures; Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset; Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized rTMS based on fNIRS<br>Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS. | Procedure: individual rTMS based on fNIRS<br>* The rTMS parameters will be set according to fNIRS results.<br>|
| Active Comparator: Traditional rTMS strategy<br>The control group will always be given low-frequency rTMS to contralesional M1 | Procedure: Traditional rTMS strategy<br>* The low-frequency rTMS to contralesional M1 will always be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Ashworth scale | The range is 0-Ⅳ level, the higher the level, the higher the spasticity. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment of upper limb motor function | The score range is 0-66 points, the higher the score, the better the motor function of upper limb. | 1 month | 
| Barthel index | The score range is 0-100 points, the higher the score, the better the activities of daily living. | 1 month | 
| average weighted clustering coefficient | This is a brain network indicator based on graph theory. It is a measure of the local separation of the graph. The higher the average weighted clustering coefficient, the higher the degree of segregation of the brain network. | 1 month | 
| global efficiency | This is a brain network indicator based on graph theory. It is a measure of the local integration of the graph. The higher the global efficiency, the stronger the ability of the network to transmit information. | 1 month | 
| inter-density | It is a brain network indicator based on graph theory and is defined as the ratio of the actual number of connections among all possible connections between bilateral hemispheres. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Spasticity, Muscle, Rehabilitation, fNIRS, rTMS, Activation, Brain network