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Individualized rTMS Based on fNIRS to Spasticity

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05318586
Enrollment
20
Registered
2022-04-08
Start date
2022-04-10
Completion date
2023-12-31
Last updated
2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Spasticity, Muscle, Stroke

Keywords

Stroke, Spasticity, Muscle, Rehabilitation, fNIRS, rTMS, Activation, Brain network

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.

Interventions

PROCEDUREindividual rTMS based on fNIRS

The rTMS parameters will be set according to fNIRS results.

The low-frequency rTMS to contralesional M1 will always be used.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
modified Ashworth scale1 monthThe range is 0-Ⅳ level, the higher the level, the higher the spasticity.

Secondary

MeasureTime frameDescription
Fugl-Meyer Assessment of upper limb motor function1 monthThe score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Barthel index1 monthThe score range is 0-100 points, the higher the score, the better the activities of daily living.
average weighted clustering coefficient1 monthThis 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 efficiency1 monthThis 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-density1 monthIt 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.

Countries

China

Contacts

Primary ContactZiwen Yuan, MD
yuanziwen@xjtufh.edu.cn+8617502991129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026