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Status unknownNCT05318586Updated Apr 20, 2022

Individualized rTMS Based on fNIRS to Spasticity

An interventional study of individual rTMS based on fNIRS and Traditional rTMS strategy in Stroke, Spasticity, Muscle and Rehabilitation, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 40 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Spasticity, Muscle
  • Rehabilitation

Keywords

  • Stroke
  • Spasticity, Muscle
  • Rehabilitation
  • fNIRS
  • rTMS
  • Activation
  • Brain network
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • Active comparator
    Traditional rTMS strategy

    The control group will always be given low-frequency rTMS to contralesional M1

    Procedure: Traditional rTMS strategy

Interventions

  • Procedureindividual rTMS based on fNIRS

    The rTMS parameters will be set according to fNIRS results.

  • ProcedureTraditional rTMS strategy

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

06

What researchers measure

Primary outcomes

  1. modified Ashworth scale

    The range is 0-Ⅳ level, the higher the level, the higher the spasticity.

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

  2. Barthel index

    The score range is 0-100 points, the higher the score, the better the activities of daily living.

    Time frame: 1 month

  3. 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.

    Time frame: 1 month

  4. 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.

    Time frame: 1 month

  5. 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.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05318586
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Apr 8, 2022
Start date
Apr 10, 2022
Primary completion
Sep 1, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 20, 2022

Study contacts

Ziwen Yuan, MD
Contact
yuanziwen@xjtufh.edu.cn
+8617502991129

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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