Integrated Eye Tracking and Neural Monitoring for Enhance... | NCT03777228

Studies
Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study

NCT03777228

Sponsor

Uniformed Services University of the Health Sciences

Status

Completed

Last Update Posted

Dec 17, 2018Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Mild Traumatic Brain Injury

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

Jun 2017

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

Apr 15, 2015Actual

Primary Completion Date

Mar 15, 2017Actual

Completion Date

Mar 15, 2017Actual

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 17, 2018Actual

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

Dec 14, 2018

Last Update Posted Date

Dec 17, 2018Actual

Description Module

Brief Summary

This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Individuals without traumatic brain injury
Mild TBI		Individuals with mild traumatic brain injury
Moderate to Severe TBI		Individual with moderate to severe traumatic brain injury

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Saccadic RT	Saccadic Response Time	1 day (single time point)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English

Exclusion Criteria:

history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Participants will be recruited through USUHS, the Walter Reed National Military Medical Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in the surrounding community, and in clinical settings such as such as concussion clinics, neurorehabilitation centers, and other local private practices.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001924	Brain Concussion
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided