StrokeNCT05318586
Individualized rTMS Based on fNIRS to Spasticity
A study testing individual rTMS based on fNIRS and Traditional rTMS strategy in people with Stroke and Spasticity, Muscle, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spasticity, Muscle, Rehabilitation
- What is being tested?
- individual rTMS based on fNIRS and Traditional rTMS strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-79 years;
- Patients with first-onset stroke within 1 to 3 months after onset;
- Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment;
- 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
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Ziwen Yuan, MD., +86 17502991129, yuanziwen@xjtufh.edu.cn
About this study
Official title: Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke
Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity.
- Conditions
- Stroke, Spasticity, Muscle, Rehabilitation
- Being tested
- individual rTMS based on fNIRS, Traditional rTMS strategy
- Keywords
- Stroke, Spasticity, Muscle, Rehabilitation, fNIRS, rTMS, Activation, Brain network
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual rTMS based on fNIRSProcedure or surgery
The rTMS parameters will be set according to fNIRS results.
Traditional rTMS strategyProcedure or surgery
The low-frequency rTMS to contralesional M1 will always be used.
| Study group | Role | What they receive |
|---|---|---|
| Individualized rTMS based on fNIRS | Experimental | Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS. Receives: Procedure: individual rTMS based on fNIRS |
| Traditional rTMS strategy | Active comparator | The control group will always be given low-frequency rTMS to contralesional M1 Receives: Procedure: Traditional rTMS strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Ashworth scale
The range is 0-Ⅳ level, the higher the level, the higher the spasticity.
Measured: 1 month
Secondary outcomes (5)
Fugl-Meyer Assessment of upper limb motor function
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Measured: 1 month
Barthel index
The score range is 0-100 points, the higher the score, the better the activities of daily living.
Measured: 1 month
average weighted clustering coefficient
This is a brain network indicator based on graph theory. It is a measure of the local separation of the graph. The higher the average weighted clustering coefficient, the higher the degree of segregation of the brain network.
Measured: 1 month
global efficiency
This is a brain network indicator based on graph theory. It is a measure of the local integration of the graph. The higher the global efficiency, the stronger the ability of the network to transmit information.
Measured: 1 month
inter-density
It is a brain network indicator based on graph theory and is defined as the ratio of the actual number of connections among all possible connections between bilateral hemispheres.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start10 Apr 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Dec 2023 (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
- 20 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
- NCT05318586
- Sponsor's protocol ID
- 2022JQ-982
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke
- ClinicalTrials.gov ID
- NCT05318586
- Acronym / sponsor ID
- 2022JQ-982
- Conditions
- Stroke, Spasticity, Muscle, Rehabilitation
- Keywords
- Stroke, Spasticity, Muscle, Rehabilitation, fNIRS, rTMS, Activation, Brain network
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Apr 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 of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity.
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 based on fNIRS | Experimental | Procedure: individual rTMS based on fNIRSLow-frequency rTMS will be given to the most active brain regions assessed by fNIRS. |
| Traditional rTMS strategy | Active comparator | Procedure: 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 40-79 years;
- Patients with first-onset stroke within 1 to 3 months after onset;
- Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment;
- 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 |
|---|---|---|
| individual rTMS based on fNIRSThe rTMS parameters will be set according to fNIRS results. | Procedure or surgery | Individualized rTMS based on fNIRS |
| Traditional rTMS strategyThe low-frequency rTMS to contralesional M1 will always be used. | Procedure or surgery | Traditional rTMS strategy |
Primary outcome
modified Ashworth scale
Time frame: 1 month
The range is 0-Ⅳ level, the higher the level, the higher the spasticity.
5 secondary outcomes
Fugl-Meyer Assessment of upper limb motor function
Time frame: 1 month
Barthel index
Time frame: 1 month
average weighted clustering coefficient
Time frame: 1 month
global efficiency
Time frame: 1 month
inter-density
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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 individual rTMS based on fNIRS and Traditional rTMS strategy in people with Stroke and Spasticity, Muscle, 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 4 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 20 Apr 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?
modified Ashworth scale (time frame: 1 month). 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 20 Apr 2022; AzTrials last refreshed its copy on 27 Oct 2026.