Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke

Stroke Clinical Trial

Official title:

Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke: a Resting-state fMRI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648552
• Other study ID #: 2022-LCYJ-PY-27
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Wenjun Hong
• Phone: +86 13851924571
• Email: hongwenjun1989[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Activity
• Stroke

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural-functional Connectivity Coupling	The coupling between structural connectivity and functional connectivity	Within 1 week after enrollment
Primary	Fugl-Meyer Assessment	Assessing the motor function in post-stroke participants	Within 1 week after enrollment
Secondary	Chinese version of Modified Barthel Index	Assessing the activities of daily living in post-stroke participants	Within 1 week after enrollment
Secondary	Broetz Hand Test	Assessing the hemiplegic hand performance in post-stroke participants	Within 1 week after enrollment
Secondary	Placebo Questionnaire	Self-evaluation of rehabilitation treatment in post-stroke participants	Within 1 week after enrollment
Secondary	Hamilton Depression Rating Scale	Assessing the depression in post-stroke participants	Within 1 week after enrollment
Secondary	Chinese (Putonghua) Version of Oxford Cognitive Screen	Assessing the cognition in post-stroke participants	Within 1 week after enrollment