Individualized rTMS Based on fNIRS to Spasticity

Not Applicable

• Conditions: Spasticity, Muscle; Rehabilitation; Stroke
• Interventions: Procedure: individual rTMS based on fNIRS; Procedure: Traditional rTMS strategy

• Registration Number: NCT05318586
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-08
• Study Start: 2022-04-10
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized rTMS based on fNIRS	individual rTMS based on fNIRS	Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.
Traditional rTMS strategy	Traditional rTMS strategy	The control group will always be given low-frequency rTMS to contralesional M1

Primary Outcome Measures

Name	Time	Method
modified Ashworth scale	1 month	The range is 0-Ⅳ level, the higher the level, the higher the spasticity.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China