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

NCT ID: NCT01459692

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seizures Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group - No Music Exposure

Subjects that were assigned to the control group of the study were not exposed to music.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Music Exposure

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MIND Research Institute

UNKNOWN

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert P Turner, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Mark Bodner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

MIND Research Institute

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23071510 (View on PubMed)

Other Identifiers

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HR15863

Identifier Type: -

Identifier Source: org_study_id

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