Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke

NCT05440292 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-30

No results posted yet for this study

Summary

Stroke is a global health problem and a leading cause of disability. Limitation of upper limb function occurs in 55 -75% of patients after stroke. In recent years, non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have been shown that can promote functional recovery in stroke patients, and multiple studies have reported that low-frequency rTMS stimulation on the motor areas of the unaffected hemispheres of stroke patients can significantly improve motor function of the affected upper limb. The standard procedure for TMS to determine the primary motor area is to measure hotspot, which is used as a common target for movement disorders such as hemiplegia after stroke. In the 1990s, the hands-on task activation point determined by functional magnetic resonance imaging(fMRI) and positron emission computed tomography(PET) studies was located at "Hand Knob" in the primary motor area. The study found that although the hands-on task activation point was closer to hotspot, it was significantly different from hotspot. The hands-on task activation point had stronger functional connection with the whole brain, especially the motor cognition-related brain area. Therefore, this study aims to compare the efficacy of rTMS stimulation on individual rTMS targets(task fMRI activation point) with traditional hotspot in patients with post-stroke hemiplegia. The regulation effect of rTMS was evaluated by using local brain function indicators and functional connections, and the longitudinal change pattern of brain function before and after treatment was observed to explore the therapeutic targets of rTMS for motor dysfunction after stroke and the mechanism of brain functional plasticity.

Conditions

  • Stroke
  • Transcranial Magnetic Stimulation
  • Functional Magnetic Resonance Imaging
  • Upper Extremity Dysfunction
  • Brain Plasticity

Interventions

DEVICE

Transcranial magnetic stimulation

For each stimulation day, low-frequency (1 Hz) ,1800 pulses(intensity of 100% resting motor threshold(RMT), duration 30 min) rTMS stimulation were delivered on the hotspot of unaffected hemisphere(Hotspot-rTMS Group) and the motor task activation poin of unaffected hemisphere(fMRI-rTMS Group). rTMS which guided by individualized navigation delivery 5 days a week for 4 weeks.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440292 on ClinicalTrials.gov