Neurocognitive and Radiological Assessments in Adult Moyamoya Undergoing Surgery

Moyamoya Disease Clinical Trial

— NRAAMUS  

Official title:

Neurocognitive and Radiological Assessments in Adult Patients With Moyamoya Disease Undergoing Surgical Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02305407
• Other study ID #: VCI2014
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2014
• Last updated: August 21, 2017
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2017
• Source: Huashan Hospital
• Contact: Yu Lei, MD
• Phone: +86 021 52889999
• Email: piliyouxia_lei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moyamoya Disease

Intervention

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.

Other:
• Conservative treatment
Patients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.

Locations

Country	Name	City	State
China	Department of Neurosurgery, Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of participants who suffer from all stroke or death during 30 days to 24 months		24 months
Secondary	The number of participants who suffer from all kinds of adverse events related to surgery.		30 days
Secondary	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.	average of 1 week after surgery
Secondary	Postoperative radiological outcomes before discharge.	Measure cerebral perfusion simultaneously with neurocognitive testing, using the single photon emission computed tomography (SPECT).	average of 1 week after surgery
Secondary	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
Secondary	The changes from baseline in single photon emission computed tomography (SPECT).		2 years
Secondary	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.	2 years