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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03451058
Other study ID # NMCSD.2017.0012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 7, 2017
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source United States Naval Medical Center, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Traumatic brain injury (TBI) is one of the most frequent injuries affecting service members. Unfortunately, current neurocognitive assessment tools are unable to reliably detect mild TBI more than a few days post- injury. Therefore, development of advanced systems for assessment and diagnosis of TBI are a top priority within Department of Defense. This project aims to evaluate a combined electroencephalography (EEG) and eye tracking system capable of assessing compromised cognitive function stemming from TBI, with the goal of enhancing operational readiness and aiding in diagnosis, improving health care and rehabilitation for affected military personnel.


Description:

This study (N=100) will be a correlational study to assess cognitive function in healthy controls, individuals with mild TBI, and individuals with moderate-to-severe TBI. In general, participants will provide demographic information, medical history, and details of their head injury. Participants will also complete a brief neuropsychological assessment to obtain an index of cognitive ability, along with the Fusion Test with eye tracking and linked EEG. MRI data may also be obtained.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: All groups: - Ability to use dominant hand to complete cognitive and motor tasks - Fluent in English Mild TBI group: - History of mild TBI > 3 months and < 10 years prior to enrollment - Self-report of post-concussive symptoms Moderate-to-Severe TBI group: - History of moderate or severe TBI > 3 months and < 10 years prior to enrollment Exclusion Criteria: Control group: History of possible or confirmed brain injury All groups: - History of a medical condition (other than brain injury) that would be expected to affect cognitive or motor abilities (e.g. muscular dystrophy, multiple sclerosis, or psychotic disorders such as schizophrenia) - Presence of neurological condition, such as brain tumor, brain infection, seizure, or stroke - Presence of visual impairment that is uncorrected by glasses or contacts (including color blindness) - Evidence of current suicidal or homicidal ideation

Study Design


Locations

Country Name City State
United States Naval Medical Center San Diego San Diego California

Sponsors (3)

Lead Sponsor Collaborator
United States Naval Medical Center, San Diego The Defense and Veterans Brain Injury Center, Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task. One study visit
Primary Eye Tracking Saccadic latencies measured in response to cognitive task including working memory demands. One study visit
Secondary Neurobehavioral Symptom Inventory (NSI) Self-report measure of post-concussive symptoms One study visit
Secondary Trail Making Test Consists of Part A and B which depends on psychomotor speed, visual search abilities, and placing demands on working memory and cognitive flexibility One study visit
Secondary Symbol Search Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed One study visit
Secondary Digit Span WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span. One study visit
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