Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke

Recruiting

• Conditions: Stroke; Motor Activity

• Registration Number: NCT05648552
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China