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
  Purpose

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).


Condition Intervention
Seizures
Epilepsy
Other: Music Exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459692

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29412
Sponsors and Collaborators
Medical University of South Carolina
MIND Institute
Investigators
Principal Investigator: Robert P Turner, MD, MSCR Medical University of South Carolina
Principal Investigator: Mark Bodner, Ph.D. MIND Research Institute
  More Information

No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01459692     History of Changes
Other Study ID Numbers: HR15863
Study First Received: October 24, 2011
Last Updated: October 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Seizures
Epilepsy
Auditory Stimulation
Music

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014