Neuropsychological Testing Using Mobile Devices | NCT01776086

Studies
Neuropsychological Testing Using Mobile Devices

NCT01776086

Sponsor

Englewood Hospital and Medical Center

Status

Withdrawn

Last Update Posted

Jul 10, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Inpatients With Normal Neurological Function

Interventions

Neurological testing

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no subjects agreed to participate

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jul 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jan 23, 2013

First Submission Date that Met QC Criteria

Jan 24, 2013

First Posted Date

Jan 25, 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

Jul 9, 2013

Last Update Posted Date

Jul 10, 2013Estimated

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 studying is to develop and characterize neuropsychological testing software for evaluating the prefrontal and temporal function of patients. As no software has been used for this purpose, this study will gather pilot data on the baseline performance of patients in a hospital setting that lack any neurological impairment. After creating this baseline, later experiments can be proposed to compare the performance in normal subjects with those who have neurologic injury or disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal patients	Other	for patients with normal score on neurological testing with Folstein Mini-Mental Status Exam will then take the Scenes Task	Behavioral: Neurological testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurological testing	Behavioral		Normal patients	Scenes Task Folstein Mini-Mental Status Exam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of "normal performance" curve	The purpose of this study is to generate a curve of "normal performance" on the neurological test for hospitalized patients of different ages	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inpatients > = 18 years of age
Patient must be able to provide informed consent

Exclusion Criteria:

Patients with score of < 26 on Folstein Mini-Mental Status Exam
Patients with known brain lesions
Patients with history of stroke, neurologic disease or dementia
Patients with acute illness or who are in imminent distress

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Young, MD, PhD	Englewood Hospital and Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Englewood Hospital and Medical Center		Englewood	New Jersey	07631	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000073216	Mental Status and Dementia Tests

Ancestor Terms

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided