Dynamic Individualized rTMS Based on fNIRS

NCT ID: NCT04617366

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2024-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individualized rTMS strategy

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.

Group Type: EXPERIMENTAL

Individualized rTMS strategy

Intervention Type: OTHER

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

Traditional rTMS strategy

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

Group Type: ACTIVE_COMPARATOR

Traditional rTMS strategy

Intervention Type: OTHER

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

Interventions

Individualized rTMS strategy

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

Intervention Type: OTHER

Traditional rTMS strategy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ziwen Yuan, MD.

Role: CONTACT

yuanziwen@xjtufh.edu.cn

+8617502991129

Facility Contacts

Ziwen Yuan, MD.

Role: primary

yuanziwen@xjtufh.edu.cn

+8617502991129

Other Identifiers

XJUFH-R-002

Identifier Type: -

Identifier Source: org_study_id