Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedMay 7, 2018
May 1, 2018
2.9 years
October 24, 2011
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in seizure rates
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.
3 years
Study Arms (2)
Control group - No Music Exposure
NO INTERVENTIONSubjects that were assigned to the control group of the study were not exposed to music.
Music Exposure
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Resident of Thad E. Saleeby Center
- Epilepsy or seizure disorder
- At least one year of detailed seizure reporting prior to study starting date
You may not qualify if:
- Severe hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinalead
- MIND Research Institutecollaborator
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29412, United States
Related Publications (1)
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.
PMID: 23071510DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert P Turner, MD, MSCR
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Mark Bodner, Ph.D.
MIND Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 26, 2011
Study Start
February 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
May 7, 2018
Record last verified: 2018-05