Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
Primary Purpose
Stroke, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hotspot-rTMS Group
fMRI-rTMS Group
Arm Description
rTMS stimulate on the hotspot of unaffected hemisphere
rTMS stimulate on the motor task activation poin (targeted by fMRI) of unaffected hemisphere
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Action Research Arm Test
Including 19 items, scores range from 0 to 57 points. The higher scores, the better upper limb function.
National Institute of Health Stroke Scale
Use for evaluating the severity of neurological impairment in stroke,including 11 items, scores range from 0 to 42 points. The higher scores, the more severe the neurological impairment.
Barthel Index
Use for evaluating the ability in activity of daily living, including 10 items,scores range from 0 to 100 points. The higher scores, the better ability in activity of daily living.
Regional homogeneity (ReHo), Amplitude of low-frequency fluctuation (ALFF), Functional connectivity (FC)
Resting state functional magnetic resonance scan.The increase of ReHo represents the enhancement of the consistency of spontaneous neural activity in local brain regions. The increase of ALFF represents the enhancement of spontaneous neural activity. The increase of FC represents the enhancement functional connectivity between different regions of brain.
Latency of motor evoked potential, Amplitude of motor evoked potential
The higher values of latency of motor evoked potential indicate the lower activity of motor cortex in brain. The higher values of amplitude of motor evoked potential indicate the higher activity of motor cortex in brain.
Surface electromyogram measurement
The affected side of the biceps brachii, triceps brachii, flexor carpi and extensor carpi dorsi. The higher values of root-mean-square and integrated electromyogram indicate the stronger muscle's ability to contract.
Full Information
NCT ID
NCT05440292
First Posted
June 19, 2022
Last Updated
June 27, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05440292
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Upper Extremity Dysfunction, Brain Plasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hotspot-rTMS Group
Arm Type
Experimental
Arm Description
rTMS stimulate on the hotspot of unaffected hemisphere
Arm Title
fMRI-rTMS Group
Arm Type
Experimental
Arm Description
rTMS stimulate on the motor task activation poin (targeted by fMRI) of unaffected hemisphere
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment-Upper Extremity
Description
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.
Time Frame
At the end of 4 weeks of rTMS
Title
Fugl-Meyer Assessment-Upper Extremity Scale
Description
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.
Time Frame
2 months after the end of rTMS
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
Including 19 items, scores range from 0 to 57 points. The higher scores, the better upper limb function.
Time Frame
At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Title
National Institute of Health Stroke Scale
Description
Use for evaluating the severity of neurological impairment in stroke,including 11 items, scores range from 0 to 42 points. The higher scores, the more severe the neurological impairment.
Time Frame
At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Title
Barthel Index
Description
Use for evaluating the ability in activity of daily living, including 10 items,scores range from 0 to 100 points. The higher scores, the better ability in activity of daily living.
Time Frame
At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Title
Regional homogeneity (ReHo), Amplitude of low-frequency fluctuation (ALFF), Functional connectivity (FC)
Description
Resting state functional magnetic resonance scan.The increase of ReHo represents the enhancement of the consistency of spontaneous neural activity in local brain regions. The increase of ALFF represents the enhancement of spontaneous neural activity. The increase of FC represents the enhancement functional connectivity between different regions of brain.
Time Frame
At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Title
Latency of motor evoked potential, Amplitude of motor evoked potential
Description
The higher values of latency of motor evoked potential indicate the lower activity of motor cortex in brain. The higher values of amplitude of motor evoked potential indicate the higher activity of motor cortex in brain.
Time Frame
At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Title
Surface electromyogram measurement
Description
The affected side of the biceps brachii, triceps brachii, flexor carpi and extensor carpi dorsi. The higher values of root-mean-square and integrated electromyogram indicate the stronger muscle's ability to contract.
Time Frame
At the end of 4 weeks of rTMS; 2 months after the end of rTMS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihui Cheng
Phone
+8618351990577
Email
chengyihui9606@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihui Cheng
Phone
+8618351990577
Email
chengyihui9606@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
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