Dynamic Individualized rTMS Based on fNIRS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation; Repetitive Transcranial Magnetic Stimulation; Functional Near-infrared Spectroscopy
• Intervention / Treatment: Other: Individualized rTMS strategy; Other: Traditional rTMS strategy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziwen Yuan, MD.; Phone Number: +8617502991129; Email: yuanziwen@xjtufh.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Ziwen Yuan, MD.; Phone Number: +8617502991129; Email: yuanziwen@xjtufh.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Individualized rTMS strategy; It will adjust the rTMS parameters based on the results of fNIRS.
Active Comparator: Traditional rTMS strategy; The control group will always be given low-frequency rTMS to contralesional M1.	Other: Traditional rTMS strategy; The patients will always be given low-frequency rTMS to contralesional M1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer motor function score of upper limb	The score range is 0-66 points, the higher the score, the better the motor function of upper limb.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel index	The score range is 0-100 points, the higher the score, the better the activities of daily living.	3 months
Lateralization index (LI)	The LI score measured by fNIRS ranges from -1 to 1, with 1 indicating purely ipsilesional and -1 indicating purely contralesional activation.	3 months
Brain functional connection network	Using fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral hemispheres.	3 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: XJUFH-R-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No