Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-04-15 @ 10:14 PM
Study NCT ID:
NCT02453958
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild Traumatic Brain Injury Discrimination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'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': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Receiver-operator-curve area under the curve (AUC)', 'timeFrame': 'up to 5 years', 'description': "Each test's discrimination capability was quantified using AUC and p value"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Injury', 'Brain', 'Traumatic Mild', 'Mild Traumatic Brain Injury'], 'conditions': ['Brain Concussion']}, 'descriptionModule': {'briefSummary': 'Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.', 'detailedDescription': 'This was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. These results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. This represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Military personnel\n* Age 18 to 45\n* Diagnosis of mTBI within past 5 years\n* Rancho Los Amigos Scale score of 7 or above\n\nExclusion Criteria:\n\n* Non-military individuals\n* Below age 18 or older than 45\n* No diagnosis of mTBI within past 5 years\n* Rancho Los Amigos Scale score of 6 or below'}, 'identificationModule': {'nctId': 'NCT02453958', 'acronym': 'MTBID', 'briefTitle': 'Mild Traumatic Brain Injury Discrimination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Empirical Technologies Corporation'}, 'officialTitle': 'Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'ETC_mTBI_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mTBI-diagnosed group', 'description': 'Subjects diagnosed with mTBI were assessed with a multi-modal assessment system.', 'interventionNames': ['Device: Multi-modal assessment system']}, {'type': 'EXPERIMENTAL', 'label': 'non mTBI-diagnosed group', 'description': 'Non-concussed subjects were assessed with a multi-modal assessment system.', 'interventionNames': ['Device: Multi-modal assessment system']}], 'interventions': [{'name': 'Multi-modal assessment system', 'type': 'DEVICE', 'description': 'Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests', 'armGroupLabels': ['mTBI-diagnosed group', 'non mTBI-diagnosed group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin C. Baruch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Empirical Technologies Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Empirical Technologies Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hunter Holmes Mcguire Veteran Affairs Medical Center', 'class': 'FED'}, {'name': 'Walter Reed Army Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}