Dynamic Individualized rTMS Based on fNIRS

Xi'an Jiaotong University

Status: Unknown

Conditions: Rehabilitation; Functional Near-infrared Spectroscopy; Stroke; Repetitive Transcranial Magnetic Stimulation

Treatments: Other: Individualized rTMS strategy; Other: Traditional rTMS strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04617366

XJUFH-R-002

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Individualized rTMS strategy

Experimental group

Description:

The individualized strategy will adjust the rTMS parameters promptly based on the results of fNIRS. This arm 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.

Treatment:

Other: Individualized rTMS strategy

Traditional rTMS strategy

Active Comparator group

Description:

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

Treatment:

Other: Traditional rTMS strategy