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Individualized rTMS Based on fNIRS to Spasticity

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Xi'an Jiaotong University

Status

Unknown

Conditions

Spasticity, Muscle
Rehabilitation
Stroke

Treatments

Procedure: individual rTMS based on fNIRS
Procedure: Traditional rTMS strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT05318586
2022JQ-982

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

40 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Individualized rTMS based on fNIRS
Experimental group
Description:
Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.
Treatment:
Procedure: individual rTMS based on fNIRS
Traditional rTMS strategy
Active Comparator group
Description:
The control group will always be given low-frequency rTMS to contralesional M1
Treatment:
Procedure: Traditional rTMS strategy

Trial contacts and locations

1

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Central trial contact

Ziwen Yuan, MD

Data sourced from clinicaltrials.gov

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