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

Moyamoya Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041659
• Other study ID #: 2023022
• Status: Recruiting
• Start date: October 24, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Beijing Tiantan Hospital
• Contact: Shu Li
• Phone: 8613699223065
• Email: lishu[@]bjtth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Moyamoya Disease

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of brain functional network		Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
Secondary	Postoperative delirium		Day1-5 after surgery
Secondary	Electroencephalogram changes		Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min