Moyamoya DiseaseNRAAMUSNCT02305407
Neurocognitive and Radiological Assessments in Adult Moyamoya Undergoing Surgery
A study testing Surgical Revascularization and Conservative treatment in people with Moyamoya Disease, run by Huashan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Surgical Revascularization and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Yuxiang Gu, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Yu Lei, MD, 862152889999, 709586957@qq.com
Jiabin Su, MD, +8613621652533, 36931280@qq.com
About this study
Official title: Neurocognitive and Radiological Assessments in Adult Patients With Moyamoya Disease Undergoing Surgical Revascularization
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.
Read the 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.
- Conditions
- Moyamoya Disease
- Being tested
- Surgical Revascularization, Conservative treatment
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical RevascularizationProcedure or surgery
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.
Conservative treatmentOther
Patients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
| Study group | Role | What they receive |
|---|---|---|
| surgical revascularization | Experimental | Patients will be assigned to either surgical or conservative treatment depending on their clinical symptoms and radiological assessment. Receives: Procedure: Surgical Revascularization |
| conservative treatment | Experimental | Normal conservative treatment without surgical intervention. Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (7)
The number of participants who suffer from all stroke or death during 30 days to 24 months
Measured: 24 months
The number of participants who suffer from all kinds of adverse events related to surgery.
Measured: 30 days
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.
Measured: average of 1 week after surgery
Postoperative radiological outcomes before discharge.
Measure cerebral perfusion simultaneously with neurocognitive testing, using the single photon emission computed tomography (SPECT).
Measured: average of 1 week after surgery
The changes from baseline in modified Rankin scale (mRS) and national institutes of health stroke scale (NIHSS).
Measured: at 7 days, 30 days, 3/6/12/24 months
The changes from baseline in single photon emission computed tomography (SPECT).
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMar 2016
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Lei, Huashan Hospital
- Investigators
- Yuxiang Gu, MD,PhD, Study chair, Department of Neurosurgery, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305407
- Sponsor's protocol ID
- VCI2014
- Acronym
- NRAAMUS
- Status last verified
- Aug 2017
- First submitted
- 19 Nov 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30688272
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Radiological Assessments in Adult Patients With Moyamoya Disease Undergoing Surgical Revascularization
- ClinicalTrials.gov ID
- NCT02305407
- Acronym / sponsor ID
- NRAAMUS / VCI2014
- Conditions
- Moyamoya Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical revascularization | Experimental | Procedure: Surgical RevascularizationPatients will be assigned to either surgical or conservative treatment depending on their clinical symptoms and radiological assessment. |
| conservative treatment | Experimental | Other: Conservative treatmentNormal conservative treatment without surgical intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical RevascularizationMost 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. | Procedure or surgery | surgical revascularization |
| Conservative treatmentPatients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation. | Other | conservative treatment |
Primary outcome
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.
7 secondary outcomes
The number of participants who suffer from all stroke or death during 30 days to 24 months
Time frame: 24 months
The number of participants who suffer from all kinds of adverse events related to surgery.
Time frame: 30 days
Postoperative neurocognitive outcomes before discharge.
Time frame: average of 1 week after surgery
Postoperative radiological outcomes before discharge.
Time frame: average of 1 week after surgery
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
The changes from baseline in single photon emission computed tomography (SPECT).
Time frame: 2 years
The changes from baseline in blood oxygen level-dependent functional magnetic resonance imaging (BOLD fMRI) during rest.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 30688272Su 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxiang Gu, MD,PhD contact
Yuxiang Gu, MD,PhD study chair
Department of Neurosurgery, Huashan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Revascularization and Conservative treatment in people with Moyamoya Disease, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Lei, MD (+86 021 52889999, piliyouxia_lei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive outcomes at 3/6/12/24-month follow-up after surgical revascularization or conservative treatment. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.