Individualized rTMS Based on fNIRS to Spasticity

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05318586

Collaborator

(none)

Enrollment

Location

Arms

20.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Spasticity, Muscle Rehabilitation	Procedure: individual rTMS based on fNIRS Procedure: Traditional rTMS strategy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Individualized rTMS based on fNIRS

Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.

Procedure: individual rTMS based on fNIRS

The rTMS parameters will be set according to fNIRS results.

Active Comparator: Traditional rTMS strategy

The control group will always be given low-frequency rTMS to contralesional M1

Procedure: Traditional rTMS strategy

The low-frequency rTMS to contralesional M1 will always be used.

Outcome Measures

Primary Outcome Measures

modified Ashworth scale [1 month]
The range is 0-Ⅳ level, the higher the level, the higher the spasticity.

Secondary Outcome Measures

Fugl-Meyer Assessment of upper limb motor function [1 month]
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Barthel index [1 month]
The score range is 0-100 points, the higher the score, the better the activities of daily living.
average weighted clustering coefficient [1 month]
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.
global efficiency [1 month]
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.
inter-density [1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.