The Evolution and Prognosis of Moyamoya Disease

NCT05619068 | Recruiting

• 1 other identifier: MMD-301
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the evolution of imaging appearances and cognitive function of Moyamoya disease (MMD) and to establish a prognosis evaluation system based on imaging biomarkers in MMD. The study may be helpful to optimize and improve the diagnosis and pretreatment assessment of MMD, and provide an important theoretical supplement to the existing guidelines for the management of MMD.

Conditions

Moyamoya Disease; Revascularization; Cognitive Impairment; Functional Impairment

Keywords

Moyamoya disease; Revascularization; Cognitive impairment; Functional impairment

Outcome Measures

Primary Outcomes (1)

• Rate of Cognitive decline

  Cognitive decline was defined as decreasing in any of the scale below. Choice reaction time was used as the baseline condition and the index of movement ability. Nonverbal matrix reasoning was used to assess general intelligence and reasoning ability. The Eight-item Interview to Differentiate Aging and Dementia questionnaire was used to determine the degree of cognitive decline in daily life. The mental rotation was used to evaluate the visual-spatial ability. Verbal working memory was used to measure working memory capacity. All cognitive assessment were tested using an Online Psychological Experimental System.

  1-5 years

Secondary Outcomes (2)

• Changes of functional connectivity

  1-5 years

• Changes of perfusion status

  1-5 years

Study Arms (2)

Medical treatment group

Conservative medical treatment

Surgical treatment group

Direct revascularization, indirect revascularization or combined revascularization

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients confirmed with Moyamoya disease.

You may qualify if:

• Patients with MMD: Conventional angiography or MRI examination conforms to the Guidelines for Diagnosis and Treatment of MMD (Neurol Med Chir (Tokyo) 52, 245-266, 2012), It is characterized by stenosis or occlusion of the end of the internal carotid artery, anterior cerebral artery and/or the beginning of the middle cerebral artery of unknown cause, accompanied by dilatation of the perforating artery at the base of the brain or of capillaries on the surface of the brain, i.e., the formation of smoke vessels. Sign the informed consent. Older than 10 and younger than 60. The education level of patients reached primary school or above (years of education ≥6).

You may not qualify if:

• Patients with massive cerebral infarction, multiple paraventricular ischemic foci, or significantly enlarged ventricular hydrocephalus after intracerebral hemorrhage. Patients with vascular diseases caused by immune system disease. Patients can not cooperate to complete the cognitive function test. There are other neuropsychiatric diseases that affect cognitive function (such as Alzheimer's disease, Parkinson's disease, depression, anxiety disorder, cerebral hemorrhage, hydrocephalus, craniocerebral trauma, etc.). Patients with contraindications of magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies) or unable to complete image collection.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lou Xin, MD, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Jinhao Lyu

CONTACT

+8615903562929; 330322990@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 16, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

CN (1)