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

NCT05440292 | Unknown DMC

• 1 other identifier: Xiao Lu
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment-Upper Extremity

  Only scoring for the upper limb motor function, including 33 items, scores range from 0 to 66 points. The higher scores, the better upper limb function.

  At the end of 4 weeks of rTMS

• Fugl-Meyer Assessment-Upper Extremity Scale

  Only scoring for the upper limb motor function, including 33 items, scores range from 0 to 66 points. The higher scores, the better upper limb function.

  2 months after the end of rTMS

Secondary Outcomes (6)

• Action Research Arm Test

  At the end of 4 weeks of rTMS; 2 months after the end of rTMS

• National Institute of Health Stroke Scale

  At the end of 4 weeks of rTMS; 2 months after the end of rTMS

• Barthel Index

  At the end of 4 weeks of rTMS; 2 months after the end of rTMS

• Regional homogeneity (ReHo), Amplitude of low-frequency fluctuation (ALFF), Functional connectivity (FC)

  At the end of 4 weeks of rTMS; 2 months after the end of rTMS

• Latency of motor evoked potential, Amplitude of motor evoked potential

  At the end of 4 weeks of rTMS; 2 months after the end of rTMS

Study Arms (2)

Hotspot-rTMS Group

EXPERIMENTAL

rTMS stimulate on the hotspot of unaffected hemisphere

Device: Transcranial magnetic stimulation

fMRI-rTMS Group

EXPERIMENTAL

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

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation 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.

Hotspot-rTMS Group; fMRI-rTMS Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of muscle relaxation drugs recently;
• A history of epilepsy;
• History of other neuropsychiatric diseases;
• Other motor system diseases;
• History of head trauma and serious heart disease;
• 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.)
• Skull defect was closed with metal plate at TMS stimulation site;
• Patients with skull defect;
• Other severe systemic diseases or clinical critical conditions (respiratory or hemodynamic instability);
• Refuse to participate in the trial.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Yihui Cheng

CONTACT

+8618351990577; chengyihui9606@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 30, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)