Individualized rTMS Based on fNIRS to Spasticity
Primary Purpose
Stroke, Spasticity, Muscle, Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
individual rTMS based on fNIRS
Traditional rTMS strategy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Spasticity, Muscle, Rehabilitation, fNIRS, rTMS, Activation, Brain network
Eligibility Criteria
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.
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Individualized rTMS based on fNIRS
Traditional rTMS strategy
Arm Description
Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.
The control group will always be given low-frequency rTMS to contralesional M1
Outcomes
Primary Outcome Measures
modified Ashworth scale
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
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Barthel index
The score range is 0-100 points, the higher the score, the better the activities of daily living.
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.
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.
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.
Full Information
NCT ID
NCT05318586
First Posted
March 29, 2022
Last Updated
April 18, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05318586
Brief Title
Individualized rTMS Based on fNIRS to Spasticity
Official Title
Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity, Muscle, Rehabilitation
Keywords
Stroke, Spasticity, Muscle, Rehabilitation, fNIRS, rTMS, Activation, Brain network
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individualized rTMS based on fNIRS
Arm Type
Experimental
Arm Description
Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.
Arm Title
Traditional rTMS strategy
Arm Type
Active Comparator
Arm Description
The control group will always be given low-frequency rTMS to contralesional M1
Intervention Type
Procedure
Intervention Name(s)
individual rTMS based on fNIRS
Intervention Description
The rTMS parameters will be set according to fNIRS results.
Intervention Type
Procedure
Intervention Name(s)
Traditional rTMS strategy
Intervention Description
The low-frequency rTMS to contralesional M1 will always be used.
Primary Outcome Measure Information:
Title
modified Ashworth scale
Description
The range is 0-Ⅳ level, the higher the level, the higher the spasticity.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment of upper limb motor function
Description
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Time Frame
1 month
Title
Barthel index
Description
The score range is 0-100 points, the higher the score, the better the activities of daily living.
Time Frame
1 month
Title
average weighted clustering coefficient
Description
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.
Time Frame
1 month
Title
global efficiency
Description
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.
Time Frame
1 month
Title
inter-density
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziwen Yuan, MD
Phone
+8617502991129
Email
yuanziwen@xjtufh.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziwen Yuan, MD.
Phone
+86 17502991129
Email
yuanziwen@xjtufh.edu.cn
12. IPD Sharing Statement
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Individualized rTMS Based on fNIRS to Spasticity
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