Individualized rTMS Based on fNIRS to Spasticity

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318586
• Other study ID #: 2022JQ-982
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ziwen Yuan, MD
• Phone: +8617502991129
• Email: yuanziwen[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Rehabilitation
• Spasticity, Muscle
• Stroke

Intervention

Procedure:
• individual rTMS based on fNIRS
The rTMS parameters will be set according to fNIRS results.
• Traditional rTMS strategy
The low-frequency rTMS to contralesional M1 will always be used.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Ashworth scale	The range is 0-? level, the higher the level, the higher the spasticity.	1 month
Secondary	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
Secondary	Barthel index	The score range is 0-100 points, the higher the score, the better the activities of daily living.	1 month
Secondary	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
Secondary	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
Secondary	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