Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Motor Activity

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Wenjun Hong; Phone Number: +86 13851924571; Email: hongwenjun1989@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Wenjun Hong; Phone Number: +86 13851924571; Email: hongwenjun1989@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

7. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stroke group; Chronic subcortical stroke participants with motor dysfunction
Healthy controls group; Well-matched healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural-functional Connectivity Coupling	The coupling between structural connectivity and functional connectivity	Within 1 week after enrollment
Fugl-Meyer Assessment	Assessing the motor function in post-stroke participants	Within 1 week after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese version of Modified Barthel Index	Assessing the activities of daily living in post-stroke participants	Within 1 week after enrollment
Broetz Hand Test	Assessing the hemiplegic hand performance in post-stroke participants	Within 1 week after enrollment
Placebo Questionnaire	Self-evaluation of rehabilitation treatment in post-stroke participants	Within 1 week after enrollment
Hamilton Depression Rating Scale	Assessing the depression in post-stroke participants	Within 1 week after enrollment
Chinese (Putonghua) Version of Oxford Cognitive Screen	Assessing the cognition in post-stroke participants	Within 1 week after enrollment

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Stroke; Motor dysfunction; functional connectivity; structural connectivity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2022-LCYJ-PY-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No