Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-03-29 @ 2:55 AM
Study NCT ID:
NCT02069795
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], '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': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2014-02-17', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in formant frequencies', 'timeFrame': '2 months', 'description': '1\\. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.'}], 'secondaryOutcomes': [{'measure': 'Changes in duration of speech production', 'timeFrame': '2 months', 'description': 'Changes in duration of speech production in patients following concussion to recovery time .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['concussion, athlete, speech analysis'], 'conditions': ['Concussion']}, 'descriptionModule': {'briefSummary': "The waveform assessment of an athlete's speech production has a high probability of showing abnormalities after brain injury (concussions) which could be used not only for diagnosis of the concussion, but for recovery of the brain. The aim of this study is to investigate this possibility using the Cobweb automated application system for acoustic processing.", 'detailedDescription': "Concussions affect cognitive and fine muscle motor control, and these changes will be reflected in the acoustic characteristics of the vowels being produced. The methods to identify and analyze the acoustics of vowels will greatly extend the detailed understanding of vowels produced after a concussion. The identification of the changes in formant frequencies, pitch, and duration will provide the means to use these parameters as an automated diagnostic tool. The waveform assessment of the athlete's speech production has a high probability of showing brain abnormalities immediately after a suspected or diagnosed concussion at the venue of the athletic sport. The aim of this study assessment is to investigate this possibility using the Cobweb system and greatly enhance the ability to diagnose a concussion in a timely manner to remove the athlete from practice or play."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed or suspected of having a sports concussion seen in a clinical setting\n* Ages 6 -21\n\nExclusion Criteria:\n\n* Patients who have physical injuries to their lips, tongue or oral cavity will be excluded until they have healed.\n* Patients with hearing or speech abnormalities who cannot consistently produce the stimulus materials.\n* Non-native speakers who cannot read the materials or produce the stimuli consistently.\n* Patients who cannot read the materials or produce the stimuli consistently due to their age.'}, 'identificationModule': {'nctId': 'NCT02069795', 'briefTitle': 'Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Forte Sports Medicine and Orthopedics'}, 'officialTitle': 'Utilization of Speech Analysis as a Diagnostic Tool to Objectively Evaluate Early Signs of Mild Traumatic Brain Injury: A Pilot Study', 'orgStudyIdInfo': {'id': 'IRB # 1312958125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voice recording', 'description': 'Subjects voices were recorded as they spoke specific words', 'interventionNames': ['Other: Voice recording']}], 'interventions': [{'name': 'Voice recording', 'type': 'OTHER', 'armGroupLabels': ['Voice recording']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Terry G Horner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Forte Sports Medicine and Orthopedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forte Sports Medicine and Orthopedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'Waveform Communications LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Terry G Horner', 'investigatorAffiliation': 'Forte Sports Medicine and Orthopedics'}}}}