Amnesia After Surgery for Anterior Communicating Aneurysm... | NCT01919775

Studies
Amnesia After Surgery for Anterior Communicating Aneurysm： High Resolution Magnetic Resonance (MR) Imaging Findings

NCT01919775

Sponsor

Tohoku University

Status

Completed

Last Update Posted

Aug 9, 2013Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Subarachnoid Hemorrhage
Cerebral Aneurysm
Amnesia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Aug 7, 2013

First Submission Date that Met QC Criteria

Aug 7, 2013

First Posted Date

Aug 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2013

Last Update Posted Date

Aug 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shunji MUGIKURA, Principal Investigator, Associate professor of Departmetn of Diagnostic radiology, Tohoku UniversityPrincipal Investigator

Lead Sponsor

Tohoku UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with amnesia following treatment of ACoA aneurysm.

Detailed Description

Cohort register is made by experienced neuropsychologists in our institute.

MR imaging and data storage is in the department of diagnostic radiology of our institute.

MR images are evaluated by two neuroradiologists using a work station.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cerebral infarction identified and localized in the basal forebrain on MR imaging		within 15 months from the aneurysmal treatment(an expected average 4 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Amnesia

Exclusion Criteria:

Severe decreased intellectual function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with amnesia following surgical treatment of the ACoA aneurysm.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shoki Takahashi, Professor	Department of Diagnostic Radiology, Tohoku University, Graduate School of Medicine, Sendai, Japan	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D002532	Intracranial Aneurysm
D000647	Amnesia

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided