NCT02305407

Brief Summary

Adult patients with moyamoya disease (MMD) are reported to suffer from considerable impairment of executive function/attention. Although reduced cerebrovascular reserve (CVR) in frontal areas has been detected by perfusion MRI and then confirmed to be associated with executive dysfunction in adult MMD, the structural and functional changes is still unclear with progression of executive dysfunction. Furthermore, it is very important to study the association between the neurocognitive and radiological improvement after surgical revascularization, so as to help detecting cerebral regions which are involved in executive deterioration or improvement after surgery. Then the investigators can determine whether these regions can be used as indicators to decide rational therapeutic schedule and timing of adult MMD with executive dysfunction. Thus the aim of this study is to primarily find out the neuropsychological and radiological correlates in adult MMD, and then to quantitatively evaluate the effectiveness of surgical revascularization in prevention of executive dysfunction in adult MMD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

November 19, 2014

Last Update Submit

August 21, 2017

Conditions

Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive outcomes at 3/6/12/24-month follow-up after surgical revascularization or conservative treatment.

    Measure neurocognitive outcomes with a battery of neuropsychological tests covering global cognition, executive, memory, language, and visuospatial functions. It involves the Mini-mental state examination (MMSE), the Memory and Executive Screening test (MES), the Trail Making Test (TMT), the Auditory Verbal Learning Test (AVLT), the verbal fluency test (VFT), the Rey-Osterrieth complex figure test (CFT), etc.

    2 years

Secondary Outcomes (7)

  • The number of participants who suffer from all stroke or death during 30 days to 24 months

    24 months

  • The number of participants who suffer from all kinds of adverse events related to surgery.

    30 days

  • Postoperative neurocognitive outcomes before discharge.

    average of 1 week after surgery

  • Postoperative radiological outcomes before discharge.

    average of 1 week after surgery

  • The changes from baseline in modified Rankin scale (mRS) and national institutes of health stroke scale (NIHSS).

    at 7 days, 30 days, 3/6/12/24 months

  • +2 more secondary outcomes

Study Arms (2)

surgical revascularization

EXPERIMENTAL

Patients will be assigned to either surgical or conservative treatment depending on their clinical symptoms and radiological assessment.

Procedure: Surgical Revascularization

conservative treatment

EXPERIMENTAL

Normal conservative treatment without surgical intervention.

Other: Conservative treatment

Interventions

Surgical RevascularizationPROCEDURE

Most patients in this group will be performed combined procedures of superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis (EDMS). Patients not suitable for combined procedures will be performed EDMS.

surgical revascularization
Conservative treatmentOTHER

Patients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.

conservative treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right-handed Chinese people aged over 18 years
  • No evidence of recent or remote infarct in the cerebral cortical, basal ganglia, brainstem or cerebellum
  • No evidence of recent or remote intracerebral hemorrhage
  • Diagnosis confirmed by digital subtraction angiography (DSA) according to Suzuki scale
  • No surgical intervention before recruitment
  • Physically capable of cognitive testing
  • Geographically accessible and reliable for follow-up.

You may not qualify if:

  • Significant neurological diseases or psychiatric disorders that could affect cognition
  • Other cerebrovascular diseases (such as atherosclerosis or vasculitides) likely to cause focal cerebral ischemia
  • Concomitant cerebrovascular diseases (such as aneurysms or arteriovenous malformation) that need surgical intervention
  • Severe systemic diseases
  • Pregnant or perinatal stage women
  • Any diseases likely to death within 2 yeas
  • Taking drugs such as benzodiazepine clonazepam
  • Any contraindications or allergy to aspirin
  • Allergy to iodine or radiographic contrast media
  • Past history of surgical revascularization
  • Concurrent participation in any other experimental treatment trial
  • Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (1)

  • Su JB, Xi SD, Zhou SY, Zhang X, Jiang SH, Xu B, Chen L, Lei Y, Gao C, Gu YX. Microstructural damage pattern of vascular cognitive impairment: a comparison between moyamoya disease and cerebrovascular atherosclerotic disease. Neural Regen Res. 2019 May;14(5):858-867. doi: 10.4103/1673-5374.249234.

    PMID: 30688272DERIVED

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yuxiang Gu, MD,PhD

    Department of Neurosurgery, Huashan Hospital, Fudan University

    STUDY CHAIR

Central Study Contacts

Yu Lei, MD

CONTACT

+86 021 52889999piliyouxia_lei@126.com

Yuxiang Gu, MD,PhD

CONTACT

guyuxiang1972@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 2, 2014

Study Start

March 1, 2016

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

CN(1)