search
Back to results

Dynamic Individualized rTMS Based on fNIRS

Primary Purpose

Stroke, Rehabilitation, Repetitive Transcranial Magnetic Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized rTMS strategy
Traditional rTMS strategy
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized rTMS strategy

Traditional rTMS strategy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Barthel index
The score range is 0-100 points, the higher the score, the better the activities of daily living.
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.
Brain functional connection network
Using fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral hemispheres.

Full Information

First Posted
October 28, 2020
Last Updated
February 21, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
search

1. Study Identification

Unique Protocol Identification Number
NCT04617366
Brief Title
Dynamic Individualized rTMS Based on fNIRS
Official Title
Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Repetitive Transcranial Magnetic Stimulation, Functional Near-infrared Spectroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized rTMS strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional rTMS strategy
Arm Type
Active Comparator
Arm Description
The control group will always be given low-frequency rTMS to contralesional M1.
Intervention Type
Other
Intervention Name(s)
Individualized rTMS strategy
Intervention Description
It will adjust the rTMS parameters based on the results of fNIRS.
Intervention Type
Other
Intervention Name(s)
Traditional rTMS strategy
Intervention Description
The patients will always be given low-frequency rTMS to contralesional M1.
Primary Outcome Measure Information:
Title
Fugl-Meyer motor function score of upper limb
Description
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Barthel index
Description
The score range is 0-100 points, the higher the score, the better the activities of daily living.
Time Frame
3 months
Title
Lateralization index (LI)
Description
The LI score measured by fNIRS ranges from -1 to 1, with 1 indicating purely ipsilesional and -1 indicating purely contralesional activation.
Time Frame
3 months
Title
Brain functional connection network
Description
Using fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral hemispheres.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziwen Yuan, MD.
Phone
+8617502991129
Email
yuanziwen@xjtufh.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziwen Yuan, MD.
Phone
+8617502991129
Email
yuanziwen@xjtufh.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Dynamic Individualized rTMS Based on fNIRS

We'll reach out to this number within 24 hrs