search
Back to results

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

Primary Purpose

Moyamoya Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgical Revascularization
Conservative treatment
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moyamoya Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Neurosurgery, Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

surgical revascularization

conservative treatment

Arm Description

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

Normal conservative treatment without surgical intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The number of participants who suffer from all stroke or death during 30 days to 24 months
The number of participants who suffer from all kinds of adverse events related to surgery.
Postoperative neurocognitive outcomes before discharge.
Measure neurocognitive outcomes about 1 week after surgery according to participants' physical condition, using the tests mentioned in the primary outcome measurement.
Postoperative radiological outcomes before discharge.
Measure cerebral perfusion simultaneously with neurocognitive testing, using the single photon emission computed tomography (SPECT).
The changes from baseline in modified Rankin scale (mRS) and national institutes of health stroke scale (NIHSS).
The changes from baseline in single photon emission computed tomography (SPECT).
The changes from baseline in blood oxygen level-dependent functional magnetic resonance imaging (BOLD fMRI) during rest.
Data analysis techniques include amplitude of frequency fluctuation (ALFF), regional homogeneity (ReHo), independent component analysis (ICA), voxel-based morphometry analysis (VBM), etc.

Full Information

First Posted
November 19, 2014
Last Updated
August 21, 2017
Sponsor
Huashan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02305407
Brief Title
Neurocognitive and Radiological Assessments in Adult Moyamoya Undergoing Surgery
Acronym
NRAAMUS
Official Title
Neurocognitive and Radiological Assessments in Adult Patients With Moyamoya Disease Undergoing Surgical Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgical revascularization
Arm Type
Experimental
Arm Description
Patients will be assigned to either surgical or conservative treatment depending on their clinical symptoms and radiological assessment.
Arm Title
conservative treatment
Arm Type
Experimental
Arm Description
Normal conservative treatment without surgical intervention.
Intervention Type
Procedure
Intervention Name(s)
Surgical Revascularization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative treatment
Intervention Description
Patients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
Primary Outcome Measure Information:
Title
Neurocognitive outcomes at 3/6/12/24-month follow-up after surgical revascularization or conservative treatment.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The number of participants who suffer from all stroke or death during 30 days to 24 months
Time Frame
24 months
Title
The number of participants who suffer from all kinds of adverse events related to surgery.
Time Frame
30 days
Title
Postoperative neurocognitive outcomes before discharge.
Description
Measure neurocognitive outcomes about 1 week after surgery according to participants' physical condition, using the tests mentioned in the primary outcome measurement.
Time Frame
average of 1 week after surgery
Title
Postoperative radiological outcomes before discharge.
Description
Measure cerebral perfusion simultaneously with neurocognitive testing, using the single photon emission computed tomography (SPECT).
Time Frame
average of 1 week after surgery
Title
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
Title
The changes from baseline in single photon emission computed tomography (SPECT).
Time Frame
2 years
Title
The changes from baseline in blood oxygen level-dependent functional magnetic resonance imaging (BOLD fMRI) during rest.
Description
Data analysis techniques include amplitude of frequency fluctuation (ALFF), regional homogeneity (ReHo), independent component analysis (ICA), voxel-based morphometry analysis (VBM), etc.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Lei, MD
Phone
+86 021 52889999
Email
piliyouxia_lei@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxiang Gu, MD,PhD
Email
guyuxiang1972@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuxiang Gu, MD,PhD
Organizational Affiliation
Department of Neurosurgery, Huashan Hospital, Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurosurgery, Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Lei, MD
Phone
862152889999
Email
709586957@qq.com
First Name & Middle Initial & Last Name & Degree
Jiabin Su, MD
Phone
+8613621652533
Email
36931280@qq.com
First Name & Middle Initial & Last Name & Degree
Jiabin Su, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30688272
Citation
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.
Results Reference
derived

Learn more about this trial

Neurocognitive and Radiological Assessments in Adult Moyamoya Undergoing Surgery

We'll reach out to this number within 24 hrs