Individualized rTMS Based on fNIRS to Spasticity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation; Spasticity, Muscle
• Intervention / Treatment: Procedure: individual rTMS based on fNIRS; Procedure: Traditional rTMS strategy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziwen Yuan, MD; Phone Number: +8617502991129; Email: yuanziwen@xjtufh.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Ziwen Yuan, MD.; Phone Number: +86 17502991129; Email: yuanziwen@xjtufh.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; rTMS; fNIRS; Activation; Brain network; Spasticity, Muscle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: 2022JQ-982

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No