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Recruiting NCT06041659

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

Observational Moyamoya Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Moyamoya Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Changes of brain functional network [Time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min]
Secondary outcome measures (2)
  • Postoperative delirium [Time frame: Day1-5 after surgery]
  • Electroencephalogram changes [Time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06041659 · 2023022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗