Altered Structural-functional Connectivity Coupling on Chronic Subcortical Stroke

NCT05648552 | Unknown

• 1 other identifier: 2022-LCYJ-PY-27
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Motor Activity

Keywords

Stroke; Motor dysfunction; MRI; structural connectivity; functional connectivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Chinese version of Modified Barthel Index

  Within 1 week after enrollment

• Broetz Hand Test

  Within 1 week after enrollment

• Placebo Questionnaire

  Within 1 week after enrollment

• Hamilton Depression Rating Scale

  Within 1 week after enrollment

• Chinese (Putonghua) Version of Oxford Cognitive Screen

  Within 1 week after enrollment

Study Arms (2)

Stroke group

Chronic subcortical stroke participants with motor dysfunction

Healthy controls group

Well-matched healthy controls

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• First onset unilateral subcortical stroke (basal ganglia, thalamus, internal capsule, corona radiata, lateral ventricles, etc.).
• Age ranged from 30 to 75 years old.
• Right-handedness before stroke.
• Greater than three months since stroke onset and Brunnstrom graded as III-VI; 6. The condition and vital signs are stable.
• \. Sign the informed consent form.

You may not qualify if:

• Any contraindications for the MRI examination.
• History of other brain diseases and drug dependency.
• Unstable conditions or accompanied by malignant and rapidly progressing diseases, such as severe atrial fibrillation.
• Serious communication barriers, cognitive impairment, or cooperation with difficulties.

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• Hong W, Liu Z, Zhang X, Li M, Yu Z, Wang Y, Wang M, Wu Y, Fang S, Yang B, Xu R, Zhao Z. Distance-related functional reorganization predicts motor outcome in stroke patients. BMC Med. 2024 Jun 18;22(1):247. doi: 10.1186/s12916-024-03435-7.

  PMID: 38886774 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenjun Hong

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Wenjun Hong

CONTACT

+86 13851924571; hongwenjun1989@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

CN (1)