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Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06041659
Collaborator
(none)
48
Enrollment
1
Location
27
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    48 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Functional Magnetic Resonance-Based Observations of Brain Networks and Cerebrovascular Reactivity in Patients With Moyamoya Disease Under Anesthetic Sedation, A Prospective Observational Cohort Study
    Anticipated Study Start Date :
    Sep 30, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Changes of brain functional network [Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min]

    Secondary Outcome Measures

    1. Postoperative delirium [Day1-5 after surgery]

    2. Electroencephalogram changes [Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with ischemic moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery

    • Age between 18-65 years

    • Obtain written informed consent.

    Exclusion Criteria:

    • Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination

    • Preoperative cranial imaging suggesting cerebral infarction lesion diameter >15mm

    • Patients allergic to anesthetic drugs

    • Metal implants in the body

    • Undergoing other experimental drug or instrumentation trials

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100070

    Sponsors and Collaborators

    • Beijing Tiantan Hospital

    Investigators

    • Principal Investigator: Shu Li, Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuming Peng, Clinical Professor, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT06041659
    Other Study ID Numbers:
    • 2023022
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yuming Peng, Clinical Professor, Beijing Tiantan Hospital
    Moyamoya Disease
    Cerebral Network
    Cognitive Function
    Anesthesia
    Additional relevant MeSH terms:
    Moyamoya Disease

    Study Results

    No Results Posted as of Sep 18, 2023