Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT03451058
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2017-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrated Eye Tracking and Neural Monitoring for TBI: Optimization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG', 'timeFrame': 'One study visit', 'description': 'Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.'}, {'measure': 'Eye Tracking', 'timeFrame': 'One study visit', 'description': 'Saccadic latencies measured in response to cognitive task including working memory demands.'}], 'secondaryOutcomes': [{'measure': 'Neurobehavioral Symptom Inventory (NSI)', 'timeFrame': 'One study visit', 'description': 'Self-report measure of post-concussive symptoms'}, {'measure': 'Trail Making Test', 'timeFrame': 'One study visit', 'description': 'Consists of Part A and B which depends on psychomotor speed, visual search abilities, and placing demands on working memory and cognitive flexibility'}, {'measure': 'Symbol Search', 'timeFrame': 'One study visit', 'description': 'Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed'}, {'measure': 'Digit Span', 'timeFrame': 'One study visit', 'description': 'WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic brain injury, eye tracking, EEG, cognition'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female service members with or without traumatic brain injury (TBI).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll groups:\n\n* Ability to use dominant hand to complete cognitive and motor tasks\n* Fluent in English\n\nMild TBI group:\n\n* History of mild TBI \\> 3 months and \\< 10 years prior to enrollment\n* Self-report of post-concussive symptoms\n\nModerate-to-Severe TBI group:\n\n\\- History of moderate or severe TBI \\> 3 months and \\< 10 years prior to enrollment\n\nExclusion Criteria:\n\nControl group:\n\nHistory of possible or confirmed brain injury\n\nAll groups:\n\n* 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)\n* Presence of neurological condition, such as brain tumor, brain infection, seizure, or stroke\n* Presence of visual impairment that is uncorrected by glasses or contacts (including color blindness)\n* Evidence of current suicidal or homicidal ideation'}, 'identificationModule': {'nctId': 'NCT03451058', 'briefTitle': 'Integrated Eye Tracking and Neural Monitoring for TBI: Optimization', 'organization': {'class': 'FED', 'fullName': 'United States Naval Medical Center, San Diego'}, 'officialTitle': 'Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study', 'orgStudyIdInfo': {'id': 'NMCSD.2017.0012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild TBI Group', 'description': 'History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English'}, {'label': 'Moderate to Severe TBI Group', 'description': 'History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English'}, {'label': 'Healthy Controls', 'description': 'No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}, 'collaborators': [{'name': 'Uniformed Services University of the Health Sciences', 'class': 'FED'}, {'name': 'The Defense and Veterans Brain Injury Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Head, Physical Medicine and Rehabilitation', 'investigatorFullName': 'Lynita Mullins', 'investigatorAffiliation': 'United States Naval Medical Center, San Diego'}}}}