Neurocognitive and Radiological Assessments in Adult Moyamoya Undergoing Surgery (NRAAMUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02305407
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Yu Lei, Huashan Hospital

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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Procedure: Surgical Revascularization Other: Conservative treatment Not Applicable

Detailed Description:

Previous studies of adult moyamoya disease (MMD) have revealed that vascular cognitive impairment (VCI) is the consequence of ischemic damage to dynamic factors such as cerebral hypoperfusion, rather than to cerebral gray matter. However, it is still unclear which regions are affected by MMD and how these regions respond to the progressive cognitive decline. In other way, the investigators need to detect spatial patterns in the brain activity of MMD in order to understand its pathophysiological nature.

Surgical revascularization has been accepted as the only effective form of treatment in preventing future ischemic episodes. However, its effectiveness in cognitive protection is still unknown. Thus, the investigators determine to quantitatively evaluate cognitive and radiological outcomes in adult MMD postoperatively and during follow-ups.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurocognitive and Radiological Assessments in Adult Patients With Moyamoya Disease Undergoing Surgical Revascularization
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

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Arm Intervention/treatment
Experimental: surgical revascularization
Patients will be assigned to either surgical or conservative treatment depending on their clinical symptoms and radiological assessment.
Procedure: Surgical Revascularization
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.

Experimental: conservative treatment
Normal conservative treatment without surgical intervention.
Other: Conservative treatment
Patients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.

Primary Outcome Measures :
  1. Neurocognitive outcomes at 3/6/12/24-month follow-up after surgical revascularization or conservative treatment. [ Time Frame: 2 years ]
    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.

Secondary Outcome Measures :
  1. The number of participants who suffer from all stroke or death during 30 days to 24 months [ Time Frame: 24 months ]
  2. The number of participants who suffer from all kinds of adverse events related to surgery. [ Time Frame: 30 days ]
  3. Postoperative neurocognitive outcomes before discharge. [ Time Frame: average of 1 week after surgery ]
    Measure neurocognitive outcomes about 1 week after surgery according to participants' physical condition, using the tests mentioned in the primary outcome measurement.

  4. Postoperative radiological outcomes before discharge. [ Time Frame: average of 1 week after surgery ]
    Measure cerebral perfusion simultaneously with neurocognitive testing, using the single photon emission computed tomography (SPECT).

  5. The changes from baseline in modified Rankin scale (mRS) and national institutes of health stroke scale (NIHSS). [ Time Frame: at 7 days, 30 days, 3/6/12/24 months ]
  6. The changes from baseline in single photon emission computed tomography (SPECT). [ Time Frame: 2 years ]
  7. The changes from baseline in blood oxygen level-dependent functional magnetic resonance imaging (BOLD fMRI) during rest. [ Time Frame: 2 years ]
    Data analysis techniques include amplitude of frequency fluctuation (ALFF), regional homogeneity (ReHo), independent component analysis (ICA), voxel-based morphometry analysis (VBM), etc.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02305407

Contact: Yu Lei, MD +86 021 52889999
Contact: Yuxiang Gu, MD,PhD

China, Shanghai
Department of Neurosurgery, Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Yu Lei, MD    862152889999   
Contact: Jiabin Su, MD    +8613621652533   
Sub-Investigator: Jiabin Su, MD         
Sponsors and Collaborators
Huashan Hospital
Study Chair: Yuxiang Gu, MD,PhD Department of Neurosurgery, Huashan Hospital, Fudan University

Responsible Party: Yu Lei, MD, Huashan Hospital Identifier: NCT02305407     History of Changes
Other Study ID Numbers: VCI2014
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Moyamoya Disease
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases