StrokeNCT05440292
Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
A study testing Transcranial magnetic stimulation in people with Stroke and Transcranial Magnetic Stimulation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yihui Cheng, +8618351990577, chengyihui9606@163.com
About this study
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
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hotspot-rTMS Group | Experimental | rTMS stimulate on the hotspot of unaffected hemisphere Receives: Device: Transcranial magnetic stimulation |
| fMRI-rTMS Group | Experimental | rTMS stimulate on the motor task activation poin (targeted by fMRI) of unaffected hemisphere Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months after the end of rTMS
Secondary outcomes (6)
Action Research Arm Test
Including 19 items, scores range from 0 to 57 points. The higher scores, the better upper limb function.
Measured: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
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.
Measured: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
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.
Measured: 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)
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.
Measured: 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
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.
Measured: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
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.
Measured: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440292
- Sponsor's protocol ID
- Xiao Lu
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
- ClinicalTrials.gov ID
- NCT05440292
- Acronym / sponsor ID
- Xiao Lu
- Conditions
- Stroke, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Upper Extremity Dysfunction, Brain Plasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hotspot-rTMS Group | Experimental | Device: Transcranial magnetic stimulationrTMS stimulate on the hotspot of unaffected hemisphere |
| fMRI-rTMS Group | Experimental | Device: Transcranial magnetic stimulationrTMS stimulate on the motor task activation poin (targeted by fMRI) of unaffected hemisphere |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationFor 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. | Device | Hotspot-rTMS Group, fMRI-rTMS Group |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity
Time frame: At the end of 4 weeks of rTMS
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
Time frame: 2 months after the end of rTMS
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.
6 secondary outcomes
Action Research Arm Test
Time frame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
National Institute of Health Stroke Scale
Time frame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Barthel Index
Time frame: 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)
Time frame: 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
Time frame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Surface electromyogram measurement
Time frame: At the end of 4 weeks of rTMS; 2 months after the end of rTMS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Stroke and Transcranial Magnetic Stimulation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Cheng (+8618351990577, chengyihui9606@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment-Upper Extremity (time frame: At the end of 4 weeks of rTMS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.