Clinical trial NCT05440292: Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
Official title: Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Transcranial Magnetic Stimulation
Functional Magnetic Resonance Imaging
Upper Extremity Dysfunction
Brain Plasticity
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. patients with ischemic stroke;
2. Primary onset, non-lateral motor area stroke lesion, duration of disease 15 days to 1 year;
3. Hemiplegia with unilateral hemispheric injury;
4. Brunnstrom grading (Brunnstrom, 1966)≤ STAGE IV;
5. Unconscious disorder;
6. Can cooperate to complete scale assessment, MRI scan and TMS treatment;
7. Can complete manual tasks and obtain activation points in the lateral motor area of the healthy hemisphere;
8. The head movement amplitude of all fMRI images was translational \< 2mm and rotational \< 2°;
9. Consent to rTMS treatment on the basis of conventional treatment and pass TMS safety screening;

Exclusion Criteria:

1. Use of muscle relaxation drugs recently;
2. A history of epilepsy;
3. History of other neuropsychiatric diseases;
4. Other motor system diseases;
5. History of head trauma and serious heart disease;
6. Contraindications to MRI scanning (implantable pacemaker, cardiac catheter or electronic pump; Intracerebral metal aneurysm clip, metal nail or vascular suture device; Intracerebral nerve stimulator or brain/subdural electrode, etc.)
7. Skull defect was closed with metal plate at TMS stimulation site;
8. Patients with skull defect;
9. Other severe systemic diseases or clinical critical conditions (respiratory or hemodynamic instability);
10. Refuse to participate in the trial.

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity
timeFrame: At the end of 4 weeks of rTMS
measure: Fugl-Meyer Assessment-Upper Extremity Scale
timeFrame: 2 months after the end of rTMS
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
measure: National Institute of Health Stroke Scale
timeFrame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
measure: Barthel Index
timeFrame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
measure: Regional homogeneity (ReHo), Amplitude of low-frequency fluctuation (ALFF), Functional connectivity (FC)
timeFrame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
measure: Latency of motor evoked potential, Amplitude of motor evoked potential
timeFrame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
measure: Surface electromyogram measurement
timeFrame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: