Virtual Reality Helmet to Test for Problems With Memory | NCT00454454

Studies
Virtual Reality Helmet to Test for Problems With Memory

NCT00454454

Sponsor

Emory University

Status

Completed

Last Update Posted

Jul 30, 2013Estimated

Enrollment

425Actual

Phase

Not provided

Conditions

Memory

Interventions

Not provided

Countries

United States

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

Jul 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

Mar 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 29, 2007

First Posted Date

Mar 30, 2007Estimated

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

Jul 27, 2013

Last Update Posted Date

Jul 30, 2013Estimated

Name	Class
Wallace H. Coulter Foundation	OTHER

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

The purpose of this research study is to compare a virtual reality display device with the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Detailed Description

Since many individuals with mild cognitive impairment (MCI) appear to function normally, MCI may often be recognizable through testing in advance of any changes noticed by family members or caregivers. Early and frequent testing can therefore trigger an earlier diagnosis, which may increase the effectiveness of currently available medications used to delay onset of Alzheimer's symptoms. Primary care and geriatric physicians currently lack the necessary tools required for quick and accurate MCI screening in the doctor's office environment. The current industry-standard is a battery of pen & paper neuropsychological tests that require 1.5 hours in a quiet room with a neuropsychologist.

Comparison: virtual reality display device compared to the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

425Actual

Label	Type	Description	Intervention Names
No treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 yrs of age and older
MMSE of 18 or greater or mini-cog of 4 or greater
Ability to read
Informed consent given

Exclusion Criteria:

Visual, hearing or physical impairment that would limit ability to use the virtual reality helmet or control device
Non-English speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

geriatric clinic, retirement facilities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David W Wright, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wesley Woods Health Center		Atlanta	Georgia	30322	United States
Wesley Woods Outpatient Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22110158	Result	Wright DW, Nevarez H, Kilgo P, LaPlaca M, Robinson A, Fowler S, Brumfield J, Goldstein FC. A novel technology to screen for cognitive impairment in the elderly. Am J Alzheimers Dis Other Demen. 2011 Sep;26(6):484-91. doi: 10.1177/1533317511426133. Epub 2011 Nov 22.