Clincosm LogoSign in Get a demo

Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT05648552
Collaborator
(none)
70
Enrollment
1
Location
48
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke: a Resting-state fMRI Study
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Stroke group

    Chronic subcortical stroke participants with motor dysfunction
    Healthy controls group

    Well-matched healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. Structural-functional Connectivity Coupling [Within 1 week after enrollment]

      The coupling between structural connectivity and functional connectivity

    2. Fugl-Meyer Assessment [Within 1 week after enrollment]

      Assessing the motor function in post-stroke participants

    Secondary Outcome Measures

    1. Chinese version of Modified Barthel Index [Within 1 week after enrollment]

      Assessing the activities of daily living in post-stroke participants

    2. Broetz Hand Test [Within 1 week after enrollment]

      Assessing the hemiplegic hand performance in post-stroke participants

    3. Placebo Questionnaire [Within 1 week after enrollment]

      Self-evaluation of rehabilitation treatment in post-stroke participants

    4. Hamilton Depression Rating Scale [Within 1 week after enrollment]

      Assessing the depression in post-stroke participants

    5. Chinese (Putonghua) Version of Oxford Cognitive Screen [Within 1 week after enrollment]

      Assessing the cognition in post-stroke participants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. 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.

    2. First onset unilateral subcortical stroke (basal ganglia, thalamus, internal capsule, corona radiata, lateral ventricles, etc.).

    3. Age ranged from 30 to 75 years old.

    4. Right-handedness before stroke.

    5. Greater than three months since stroke onset and Brunnstrom graded as III-VI; 6. The condition and vital signs are stable.

    6. Sign the informed consent form.

    Exclusion Criteria:

    1. Any contraindications for the MRI examination.

    2. History of other brain diseases and drug dependency.

    3. Unstable conditions or accompanied by malignant and rapidly progressing diseases, such as severe atrial fibrillation.

    4. Serious communication barriers, cognitive impairment, or cooperation with difficulties.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008

    Sponsors and Collaborators

    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Investigators

    • Study Chair: Wenjun Hong, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    ClinicalTrials.gov Identifier:
    NCT05648552
    Other Study ID Numbers:
    • 2022-LCYJ-PY-27
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Dec 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Stroke
    Motor dysfunction
    MRI
    structural connectivity
    functional connectivity
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Dec 13, 2022