StrokeNCT04617366
Dynamic Individualized rTMS Based on fNIRS
A study testing Individualized rTMS strategy and Traditional rTMS strategy in people with Stroke and Rehabilitation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Stroke, Rehabilitation, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- Individualized rTMS strategy and Traditional rTMS strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2020to 31 Mar 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-79 years;
- Patients with first-onset subcortical infarcts within1 to 3 weeks after onset;
- TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand;
- Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
- The patient or its authorized agent signs the informed consent form.
Who cannot join
- Previous seizures;
- Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
- Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Ziwen Yuan, MD., +8617502991129, yuanziwen@xjtufh.edu.cn
About this study
Official title: Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients
Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.
- Conditions
- Stroke, Rehabilitation, Repetitive Transcranial Magnetic Stimulation, Functional Near-infrared Spectroscopy
- Being tested
- Individualized rTMS strategy, Traditional rTMS strategy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized rTMS strategyOther
It will adjust the rTMS parameters based on the results of fNIRS.
Traditional rTMS strategyOther
The patients will always be given low-frequency rTMS to contralesional M1.
| Study group | Role | What they receive |
|---|---|---|
| Individualized rTMS strategy | Experimental | The individualized strategy will adjust the rTMS parameters promptly based on the results of fNIRS. This arm selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. Receives: Other: Individualized rTMS strategy |
| Traditional rTMS strategy | Active comparator | The control group will always be given low-frequency rTMS to contralesional M1. Receives: Other: Traditional rTMS strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer motor function score of upper limb
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Measured: 3 months
Secondary outcomes (3)
Barthel index
The score range is 0-100 points, the higher the score, the better the activities of daily living.
Measured: 3 months
Lateralization index (LI)
The LI score measured by fNIRS ranges from -1 to 1, with 1 indicating purely ipsilesional and -1 indicating purely contralesional activation.
Measured: 3 months
Brain functional connection network
Using fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral hemispheres.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start5 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617366
- Sponsor's protocol ID
- XJUFH-R-002
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients
- ClinicalTrials.gov ID
- NCT04617366
- Acronym / sponsor ID
- XJUFH-R-002
- Conditions
- Stroke, Rehabilitation, Repetitive Transcranial Magnetic Stimulation, Functional Near-infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 5 Nov 2020 (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 patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized rTMS strategy | Experimental | Other: Individualized rTMS strategyThe individualized strategy will adjust the rTMS parameters promptly based on the results of fNIRS. This arm selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. |
| Traditional rTMS strategy | Active comparator | Other: Traditional rTMS strategyThe control group will always be given low-frequency rTMS to contralesional M1. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 40-79 years;
- Patients with first-onset subcortical infarcts within1 to 3 weeks after onset;
- TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand;
- Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
- The patient or its authorized agent signs the informed consent form.
Key exclusion criteria (3 listed)
- Previous seizures;
- Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
- Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.
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 |
|---|---|---|
| Individualized rTMS strategyIt will adjust the rTMS parameters based on the results of fNIRS. | Other | Individualized rTMS strategy |
| Traditional rTMS strategyThe patients will always be given low-frequency rTMS to contralesional M1. | Other | Traditional rTMS strategy |
Primary outcome
Fugl-Meyer motor function score of upper limb
Time frame: 3 months
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
3 secondary outcomes
Barthel index
Time frame: 3 months
Lateralization index (LI)
Time frame: 3 months
Brain functional connection network
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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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 Individualized rTMS strategy and Traditional rTMS strategy in people with Stroke and Rehabilitation, run by First Affiliated Hospital Xi'an Jiaotong 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 5 inclusion and 3 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 23 Feb 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 Ziwen Yuan, MD. (+8617502991129, yuanziwen@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer motor function score of upper limb (time frame: 3 months). 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 23 Feb 2022; AzTrials last refreshed its copy on 28 Oct 2026.