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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT01459692

Collaborator

MIND Research Institute (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Seizures Epilepsy	Other: Music Exposure	N/A

Study Design

Study Type:

Interventional

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 :

Feb 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in seizure rates [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29412

Sponsors and Collaborators

Medical University of South Carolina
MIND Research Institute

Investigators

Principal Investigator: Robert P Turner, MD, MSCR, Medical University of South Carolina
Principal Investigator: Mark Bodner, Ph.D., MIND Research Institute