Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Primary Purpose
Seizures, Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Seizures focused on measuring Seizures, Epilepsy, Auditory Stimulation, Music
Eligibility Criteria
Inclusion Criteria:
- Resident of Thad E. Saleeby Center
- Epilepsy or seizure disorder
- At least one year of detailed seizure reporting prior to study starting date
Exclusion Criteria:
- Severe hearing impairment
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group - No Music Exposure
Music Exposure
Arm Description
Subjects that were assigned to the control group of the study were not exposed to music.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01459692
First Posted
October 24, 2011
Last Updated
May 2, 2018
Sponsor
Medical University of South Carolina
Collaborators
MIND Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01459692
Brief Title
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Official Title
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
MIND Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Epilepsy
Keywords
Seizures, Epilepsy, Auditory Stimulation, Music
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group - No Music Exposure
Arm Type
No Intervention
Arm Description
Subjects that were assigned to the control group of the study were not exposed to music.
Arm Title
Music Exposure
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Music Exposure
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in seizure rates
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Resident of Thad E. Saleeby Center
Epilepsy or seizure disorder
At least one year of detailed seizure reporting prior to study starting date
Exclusion Criteria:
Severe hearing impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Turner, MD, MSCR
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Bodner, Ph.D.
Organizational Affiliation
MIND Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23071510
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.
Results Reference
derived
Learn more about this trial
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
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