Individualized rTMS Based on fNIRS to Spasticity

NCT ID: NCT05318586

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-10
• Study Completion Date: 2023-12-31

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.

Conditions

Stroke; Spasticity, Muscle; Rehabilitation

Study Design

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

Study Groups

Individualized rTMS based on fNIRS

Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.

Group Type: EXPERIMENTAL

individual rTMS based on fNIRS

Intervention Type: PROCEDURE

The rTMS parameters will be set according to fNIRS results.

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: PROCEDURE

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

Interventions

individual rTMS based on fNIRS

The rTMS parameters will be set according to fNIRS results.

Intervention Type: PROCEDURE

Traditional rTMS strategy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

+86 17502991129

Other Identifiers

2022JQ-982

Identifier Type: -

Identifier Source: org_study_id