Dynamic Individualized rTMS Based on fNIRS

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617366
• Other study ID #: XJUFH-R-002
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ziwen Yuan, MD.
• Phone: +8617502991129
• Email: yuanziwen[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Individualized rTMS strategy
It will adjust the rTMS parameters based on the results of fNIRS.
• Traditional rTMS strategy
The patients will always be given low-frequency rTMS to contralesional M1.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Barthel index	The score range is 0-100 points, the higher the score, the better the activities of daily living.	3 months
Secondary	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
Secondary	Brain functional connection network	Using fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral hemispheres.	3 months