NCT04617366

Dynamic Individualized rTMS Based on fNIRS

Status unknown NA Last updated 23 February 2022

What this trial tests

NA trial testing Individualized rTMS strategy in Stroke in 50 participants. Status unknown.

Timeline

5 November 2020

Primary endpoint
31 December 2023

31 March 2024

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	5 November 2020
Primary completion	31 December 2023
Estimated completion	31 March 2024
Sites	1 location across China

Drugs / interventions tested

• Individualized rTMS strategy
• Traditional rTMS strategy

Conditions studied

• Stroke — all drugs for Stroke →
• Rehabilitation — all drugs for Rehabilitation →
• Repetitive Transcranial Magnetic Stimulation — all drugs for Repetitive Transcranial Magnetic Stimulation →
• Functional Near-infrared Spectroscopy — all drugs for Functional Near-infrared Spectroscopy →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 40 to 79, any sex, with Stroke or Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Task-State Cortical Motor Network Characteristics by Functional Near-Infrared Spectroscopy in Subacute Stroke Show Hemispheric Dominance.
   Yuan Z, Xu W, Bao J, Gao H, et al · · 2022 · cited 6× · PMID 35813955 · DOI 10.3389/fnagi.2022.932318
2. Resting-state and task-state fNIRS fusion assessment method for upper limb motor function in stroke patients.
   Yuan Z, Xu W, Hu Z, Guo J, et al · · 2026 · PMID 41913241 · DOI 10.1186/s12984-026-01940-9