Individualized rTMS Based on fNIRS to Spasticity
Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
April 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 20, 2022
March 1, 2022
1.4 years
March 29, 2022
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Ashworth scale
The range is 0-Ⅳ level, the higher the level, the higher the spasticity.
1 month
Secondary Outcomes (5)
Fugl-Meyer Assessment of upper limb motor function
1 month
Barthel index
1 month
average weighted clustering coefficient
1 month
global efficiency
1 month
inter-density
1 month
Study Arms (2)
Individualized rTMS based on fNIRS
EXPERIMENTALLow-frequency rTMS will be given to the most active brain regions assessed by fNIRS.
Traditional rTMS strategy
ACTIVE COMPARATORThe control group will always be given low-frequency rTMS to contralesional M1
Interventions
The rTMS parameters will be set according to fNIRS results.
The low-frequency rTMS to contralesional M1 will always be used.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
April 8, 2022
Study Start
April 10, 2022
Primary Completion
September 1, 2023
Study Completion
December 31, 2023
Last Updated
April 20, 2022
Record last verified: 2022-03