Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-01 @ 9:20 PM
Study NCT ID:
NCT01459692
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-10-25', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in seizure rates', 'timeFrame': '3 years', 'description': 'Main Outcome Measure: The effect of exposure to the auditory stimulus on seizure frequency. Changes in seizure rates from baseline to treatment years were determined and statistically compared within the treatment and control groups, as well as between the groups to assess efficacy of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Seizures', 'Epilepsy', 'Auditory Stimulation', 'Music'], 'conditions': ['Seizures', 'Epilepsy']}, 'referencesModule': {'references': [{'pmid': '23071510', 'type': 'DERIVED', 'citation': 'Bodner M, Turner RP, Schwacke J, Bowers C, Norment C. Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial. PLoS One. 2012;7(10):e45303. doi: 10.1371/journal.pone.0045303. Epub 2012 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'Neurologically-impaired individuals may have significant neurologic morbidity related to epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and potentially reversing the epileptogenic process, is of paramount importance in improving the lives of those with epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Thad E. Saleeby Center\n* Epilepsy or seizure disorder\n* At least one year of detailed seizure reporting prior to study starting date\n\nExclusion Criteria:\n\n* Severe hearing impairment'}, 'identificationModule': {'nctId': 'NCT01459692', 'briefTitle': 'Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps', 'orgStudyIdInfo': {'id': 'HR15863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group - No Music Exposure', 'description': 'Subjects that were assigned to the control group of the study were not exposed to music.'}, {'type': 'EXPERIMENTAL', 'label': 'Music Exposure', 'description': 'The treatment subjects were randomly assigned to receive nightly exposure to music at periodic intervals between the hours of 9:00 PM and 8:00 AM.', 'interventionNames': ['Other: Music Exposure']}], 'interventions': [{'name': 'Music Exposure', 'type': 'OTHER', 'description': 'Twenty-seven subjects were randomly assigned to receive nightly exposure to music at periodic intervals between the hours of 9:00 PM and 8:00 AM.', 'armGroupLabels': ['Music Exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29412', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Robert P Turner, MD, MSCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Mark Bodner, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MIND Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'MIND Research Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}