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Dynamic Individualized rTMS Based on fNIRS

Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04617366
Enrollment
50
Registered
2020-11-05
Start date
2020-11-05
Completion date
2024-03-31
Last updated
2022-02-23

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

Conditions

Functional Near-infrared Spectroscopy, Rehabilitation, Repetitive Transcranial Magnetic Stimulation, Stroke

Brief summary

Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.

Interventions

OTHERIndividualized rTMS strategy

It will adjust the rTMS parameters based on the results of fNIRS.

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

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
No

Inclusion criteria

* Aged 40-79 years; * Patients with first-onset subcortical infarcts within1 to 3 weeks after onset; * TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand; * Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment; * 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
Fugl-Meyer motor function score of upper limb3 monthsThe score range is 0-66 points, the higher the score, the better the motor function of upper limb.

Secondary

MeasureTime frameDescription
Barthel index3 monthsThe score range is 0-100 points, the higher the score, the better the activities of daily living.
Lateralization index (LI)3 monthsThe LI score measured by fNIRS ranges from -1 to 1, with 1 indicating purely ipsilesional and -1 indicating purely contralesional activation.
Brain functional connection network3 monthsUsing fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral 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