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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01459692
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
MIND Research Institute
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Seizures Epilepsy Other: Music Exposure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Study Start Date : February 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Changes in seizure rates [ Time Frame: 3 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459692


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29412
Sponsors and Collaborators
Medical University of South Carolina
MIND Research Institute
Investigators
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Principal Investigator: Robert P Turner, MD, MSCR Medical University of South Carolina
Principal Investigator: Mark Bodner, Ph.D. MIND Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01459692    
Other Study ID Numbers: HR15863
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Keywords provided by Medical University of South Carolina:
Seizures
Epilepsy
Auditory Stimulation
Music
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations