NCT04617366

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

October 28, 2020

Last Update Submit

February 21, 2022

Conditions

StrokeRehabilitationRepetitive Transcranial Magnetic StimulationFunctional Near-infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Barthel index

    3 months

  • Lateralization index (LI)

    3 months

  • Brain functional connection network

    3 months

Study Arms (2)

Individualized rTMS strategy

EXPERIMENTAL

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

Traditional rTMS strategy

ACTIVE COMPARATOR

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

Other: Traditional rTMS strategy

Interventions

Individualized rTMS strategyOTHER

It will adjust the rTMS parameters based on the results of fNIRS.

Individualized rTMS strategy
Traditional rTMS strategyOTHER

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

Traditional rTMS strategy

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ziwen Yuan, MD.

CONTACT

+8617502991129yuanziwen@xjtufh.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 5, 2020

Study Start

November 5, 2020

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

CN(1)