Traumatic Brain InjuryNCT03451058
Integrated Eye Tracking and Neural Monitoring for TBI: Optimization
An observational study of Traumatic Brain Injury, run by United States Naval Medical Center, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male and female service members with or without traumatic brain injury (TBI).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study
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.
Read the detailed 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, eye tracking, EEG, cognition
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild TBI Group | History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English | |
| Moderate to Severe TBI Group | History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English | |
| Healthy Controls | No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.
Measured: One study visit
Eye Tracking
Saccadic latencies measured in response to cognitive task including working memory demands.
Measured: One study visit
Secondary outcomes (4)
Neurobehavioral Symptom Inventory (NSI)
Self-report measure of post-concussive symptoms
Measured: One study visit
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
Measured: One study visit
Symbol Search
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed
Measured: One study visit
Digit Span
WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.
Measured: One study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start7 Jul 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences, The Defense and Veterans Brain Injury Center
- Responsible party
- Principal investigator, Lynita Mullins, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451058
- Sponsor's protocol ID
- NMCSD.2017.0012
- Status last verified
- Feb 2022
- First submitted
- 3 Oct 2017
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study
- ClinicalTrials.gov ID
- NCT03451058
- Acronym / sponsor ID
- NMCSD.2017.0012
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, eye tracking, EEG, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences, The Defense and Veterans Brain Injury Center
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild TBI Group | – | –History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English |
| Moderate to Severe TBI Group | – | –History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English |
| Healthy Controls | – | –No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male and female service members with or without traumatic brain injury (TBI).
Key inclusion criteria (8 listed)
- Ability to use dominant hand to complete cognitive and motor tasks
- Fluent in English
- History of mild TBI > 3 months and < 10 years prior to enrollment
- Self-report of post-concussive symptoms
- History of moderate or severe TBI > 3 months and < 10 years prior to enrollment
Key exclusion criteria (7 listed)
- History of possible or confirmed brain injury
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG
Time frame: One study visit
Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.
Eye Tracking
Time frame: One study visit
Saccadic latencies measured in response to cognitive task including working memory demands.
4 secondary outcomes
Neurobehavioral Symptom Inventory (NSI)
Time frame: One study visit
Trail Making Test
Time frame: One study visit
Symbol Search
Time frame: One study visit
Digit Span
Time frame: One study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: One study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.