Clinical trial NCT05648552: Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke
Official title: Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke: a Resting-state fMRI Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Motor Activity
Keywords: Stroke
Motor dysfunction
MRI
structural connectivity
functional connectivity
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Structural-functional Connectivity Coupling
timeFrame: Within 1 week after enrollment
measure: Fugl-Meyer Assessment
timeFrame: Within 1 week after enrollment
Secondary outcomes:
measure: Chinese version of Modified Barthel Index
timeFrame: Within 1 week after enrollment
measure: Broetz Hand Test
timeFrame: Within 1 week after enrollment
measure: Placebo Questionnaire
timeFrame: Within 1 week after enrollment
measure: Hamilton Depression Rating Scale
timeFrame: Within 1 week after enrollment
measure: Chinese (Putonghua) Version of Oxford Cognitive Screen
timeFrame: Within 1 week after enrollment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Wenjun Hong
role: STUDY_CHAIR
References: