Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps

This study has been completed.
Sponsor:
Collaborator:
MIND Institute
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01459692
First received: October 24, 2011
Last updated: October 25, 2011
Last verified: October 2011

October 24, 2011
October 25, 2011
February 2005
January 2008   (final data collection date for primary outcome measure)
Changes in seizure rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01459692 on ClinicalTrials.gov Archive Site
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Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps

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. During a 3-year randomized, pilot clinical trial, 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. A significant effect was observed from the auditory stimulus exposure (p<0.006).

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Seizures
  • Epilepsy
Other: Music Exposure
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.
  • No Intervention: Control group - No Music Exposure
    Subjects that were assigned to the control group of the study were not exposed to music.
  • Experimental: Music Exposure
    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: Other: Music Exposure
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
5 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01459692
HR15863
Yes
Medical University of South Carolina
Medical University of South Carolina
MIND Institute
Principal Investigator: Robert P Turner, MD, MSCR Medical University of South Carolina
Principal Investigator: Mark Bodner, Ph.D. MIND Research Institute
Medical University of South Carolina
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP