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

NCT ID: NCT05440292

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hotspot-rTMS Group

rTMS stimulate on the hotspot of unaffected hemisphere

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: DEVICE

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.

fMRI-rTMS Group

rTMS stimulate on the motor task activation poin (targeted by fMRI) of unaffected hemisphere

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yihui Cheng

Role: CONTACT

Phone: +8618351990577

Email: chengyihui9606@163.com

Facility Contacts

Yihui Cheng

Role: primary

Other Identifiers

Xiao Lu

Identifier Type: -

Identifier Source: org_study_id