StrokeNCT05648552
Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke
An observational study of Stroke and Motor Activity, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The current study aims to reveal the SC-FC coupling pattern and its relationship with motor function in post-stroke survivors with motor dysfunction by multimodal MRI. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke, Motor Activity
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Observational
- 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 30 to 75 years
- All sexes
- Adult, Older adult
Study population: To recruit 35 chronic subcortical post-stroke participants with motor dysfunction and 35 well-matched healthy controls from the Department of Rehabilitation Medicine of Nanjing Drum Tower Hospital and the local communities.
Who may be able to join
- Comply with the diagnostic criteria of "Stroke" in the 2010 "Guidelines for the Prevention and Treatment of Cerebrovascular Diseases in China," and confirmed by head CT or MRI.
- First onset unilateral subcortical stroke (basal ganglia, thalamus, internal capsule, corona radiata, lateral ventricles, etc.).
- Age ranged from 30 to 75 years old.
- Right-handedness before stroke.
- Greater than three months since stroke onset and Brunnstrom graded as III-VI; 6. The condition and vital signs are stable.
- 7. Sign the informed consent form.
Who cannot join
- Any contraindications for the MRI examination.
- History of other brain diseases and drug dependency.
- Unstable conditions or accompanied by malignant and rapidly progressing diseases, such as severe atrial fibrillation.
- Serious communication barriers, cognitive impairment, or cooperation with difficulties.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Wenjun Hong, +86 13851924571, hongwenjun1989@126.com
About this study
Official title: Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke: a Resting-state fMRI Study
The current study aims to reveal the SC-FC coupling pattern and its relationship with motor function in post-stroke survivors with motor dysfunction by multimodal MRI.
Read the detailed description
Stroke is the leading cause of death and disability in China. Recently, many previous studies suggested exploring the functional reorganization of the motor function among post-stroke survivors is urgent to be solved in both clinical work and applied basic research. Investigating the structural connectivity (SC) of the brain could visualize the anatomical connections between different brain regions and exploring the functional connectivity (FC) could reveal the functional activity patterns of the human brain in resting- and task- states. Previous studies suggested that SC-FC coupling analysis may shed light on exploring biological markers for the assessment and treatment of motor deficits in post-stroke survivors. The current study aims to reveal the SC-FC coupling pattern and its relationship with motor function in post-stroke survivors with motor dysfunction by multimodal MRI.
- Conditions
- Stroke, Motor Activity
- Keywords
- Stroke, Motor dysfunction, MRI, structural connectivity, functional connectivity
- Medical subject headings
- Stroke, Motor Activity, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | Chronic subcortical stroke participants with motor dysfunction | |
| Healthy controls group | Well-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural-functional Connectivity Coupling
The coupling between structural connectivity and functional connectivity
Measured: Within 1 week after enrollment
Fugl-Meyer Assessment
Assessing the motor function in post-stroke participants
Measured: Within 1 week after enrollment
Secondary outcomes (5)
Chinese version of Modified Barthel Index
Assessing the activities of daily living in post-stroke participants
Measured: Within 1 week after enrollment
Broetz Hand Test
Assessing the hemiplegic hand performance in post-stroke participants
Measured: Within 1 week after enrollment
Placebo Questionnaire
Self-evaluation of rehabilitation treatment in post-stroke participants
Measured: Within 1 week after enrollment
Hamilton Depression Rating Scale
Assessing the depression in post-stroke participants
Measured: Within 1 week after enrollment
Chinese (Putonghua) Version of Oxford Cognitive Screen
Assessing the cognition in post-stroke participants
Measured: Within 1 week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjun Hong, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648552
- Sponsor's protocol ID
- 2022-LCYJ-PY-27
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hong W, Wang Y, Zhang X, Wu Y, Liu Z, Zhao G, Xu R, Zhao Z. Motor-related reorganization in left inferior frontal gyrus after subcortical stroke: neurochemical basis and response to targeted neuromodulation. BMC Med. 2026 Mar 27;24(1):297. doi: 10.1186/s12916-026-04810-2.
PubMed 41896922Hong W, Liu Z, Zhang X, Li M, Yu Z, Wang Y, Wang M, Wu Y, Fang S, Yang B, Xu R, Zhao Z. Distance-related functional reorganization predicts motor outcome in stroke patients. BMC Med. 2024 Jun 18;22(1):247. doi: 10.1186/s12916-024-03435-7.
PubMed 38886774
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke: a Resting-state fMRI Study
- ClinicalTrials.gov ID
- NCT05648552
- Acronym / sponsor ID
- 2022-LCYJ-PY-27
- Conditions
- Stroke, Motor Activity
- Keywords
- Stroke, Motor dysfunction, MRI, structural connectivity, functional connectivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 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.
The current study aims to reveal the SC-FC coupling pattern and its relationship with motor function in post-stroke survivors with motor dysfunction by multimodal MRI.
Detailed description
Stroke is the leading cause of death and disability in China. Recently, many previous studies suggested exploring the functional reorganization of the motor function among post-stroke survivors is urgent to be solved in both clinical work and applied basic research. Investigating the structural connectivity (SC) of the brain could visualize the anatomical connections between different brain regions and exploring the functional connectivity (FC) could reveal the functional activity patterns of the human brain in resting- and task- states. Previous studies suggested that SC-FC coupling analysis may shed light on exploring biological markers for the assessment and treatment of motor deficits in post-stroke survivors. The current study aims to reveal the SC-FC coupling pattern and its relationship with motor function in post-stroke survivors with motor dysfunction by multimodal MRI.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | –Chronic subcortical stroke participants with motor dysfunction |
| Healthy controls group | – | –Well-matched healthy controls |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- To recruit 35 chronic subcortical post-stroke participants with motor dysfunction and 35 well-matched healthy controls from the Department of Rehabilitation Medicine of Nanjing Drum Tower Hospital and the local communities.
Key inclusion criteria (6 listed)
- Comply with the diagnostic criteria of "Stroke" in the 2010 "Guidelines for the Prevention and Treatment of Cerebrovascular Diseases in China," and confirmed by head CT or MRI.
- First onset unilateral subcortical stroke (basal ganglia, thalamus, internal capsule, corona radiata, lateral ventricles, etc.).
- Age ranged from 30 to 75 years old.
- Right-handedness before stroke.
- Greater than three months since stroke onset and Brunnstrom graded as III-VI; 6. The condition and vital signs are stable.
Key exclusion criteria (4 listed)
- Any contraindications for the MRI examination.
- History of other brain diseases and drug dependency.
- Unstable conditions or accompanied by malignant and rapidly progressing diseases, such as severe atrial fibrillation.
- Serious communication barriers, cognitive impairment, or cooperation with difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Structural-functional Connectivity Coupling
Time frame: Within 1 week after enrollment
The coupling between structural connectivity and functional connectivity
Fugl-Meyer Assessment
Time frame: Within 1 week after enrollment
Assessing the motor function in post-stroke participants
5 secondary outcomes
Chinese version of Modified Barthel Index
Time frame: Within 1 week after enrollment
Broetz Hand Test
Time frame: Within 1 week after enrollment
Placebo Questionnaire
Time frame: Within 1 week after enrollment
Hamilton Depression Rating Scale
Time frame: Within 1 week after enrollment
Chinese (Putonghua) Version of Oxford Cognitive Screen
Time frame: Within 1 week after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 41896922Hong W, Wang Y, Zhang X, Wu Y, Liu Z, Zhao G, Xu R, Zhao Z. Motor-related reorganization in left inferior frontal gyrus after subcortical stroke: neurochemical basis and response to targeted neuromodulation. BMC Med. 2026 Mar 27;24(1):297. doi: 10.1186/s12916-026-04810-2.
- Derived from this study: PubMed 38886774Hong W, Liu Z, Zhang X, Li M, Yu Z, Wang Y, Wang M, Wu Y, Fang S, Yang B, Xu R, Zhao Z. Distance-related functional reorganization predicts motor outcome in stroke patients. BMC Med. 2024 Jun 18;22(1):247. doi: 10.1186/s12916-024-03435-7.
- Individual participant dataSharing planned: Undecided
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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.
Wenjun Hong study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Motor Activity, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 6 inclusion and 4 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 Mar 2023. 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 Wenjun Hong (+86 13851924571, hongwenjun1989@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural-functional Connectivity Coupling (time frame: Within 1 week after enrollment). 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?
On the ClinicalTrials.gov record for NCT05648552, which also lists 2 linked publications.
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 Mar 2023.