Clinical trial NCT06041659: Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moyamoya Disease
Keywords: Moyamoya Disease
Cerebral Network
Cognitive Function
Anesthesia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to recruit consecutive patients with moyamoya disease who are to undergo direct or indirect revascularization surgery from August 2023 to December 2025 at Beijing Tiantan Hospital of Capital Medical University.

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.


Eligibility criteria: Inclusion Criteria:

* Patients with 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

Primary outcomes:
measure: Changes of brain functional network
timeFrame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
Secondary outcomes:
measure: Postoperative delirium
timeFrame: Day1-5 after surgery
measure: Electroencephalogram changes
timeFrame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shu Li
role: PRINCIPAL_INVESTIGATOR
References: