Scalar Localization Cochlear Electrode Array Using 64 Slice CT - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587262

Purpose

Insertion of electrode array in scala vestibuli, rather than the preferred location within scala tympani, leads to loss of native hearing in those patients with isolated high-frequency hearing loss undergoing cochlear implantation.

Condition
Hearing Loss

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The aim of our study is to determine surgical placement of the short electrode of cochlear implants in patients with high frequency loss. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices. [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	25
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Two pediatric participants with high frequency hearing loss post cochlear implant with either long or short electrode array.
2 Eight participants with high frequency hearing loss post cochlear implant with either short or long electrode array.
3 Fifteen participants from the existing Cochlear Implant data base.

Detailed Description:

We aim to determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices.

From this basis we will be able to determine if suboptimal insertion (e.g., in the scala vestibuli) leads to loss of low-frequency hearing in these patients. We also will look at the possibilities of using this data in predicting outcomes, modifying implant design, and perfecting surgical technique.

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Either part of the existing Cochlear Implant data base, or those persons who have had a Cochlear implant with either short or long electrode array who have had a high frequency hear loss.

Criteria

Inclusion Criteria:

Registered in the Cochlear Implant Database.
Patient has short or long electrode cochlear implant for high frequency hearing loss.

Exclusion Criteria:

Inability to provide consent.
Patients with underlying otospongiosis, extensive labyrinthitis ossificans or cochlear dysplasia. (These patients would have been identified with pre-operative imaging prior to cochlear implantation).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587262

Contacts

Contact: Theresa A. Nielson

507-538-2584

nielson.theresa@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: John (Jack) I. Lane, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

John (Jack) I. Lane, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

Lane JI, Witte RJ, Driscoll CL, Shallop JK, Beatty CW, Primak AN. Scalar localization of the electrode array after cochlear implantation: clinical experience using 6-slice multidetector computed tomography. Otol Neurotol. 2007 Aug;28(5):658-62.

Responsible Party:	Mayo Clinic ( John I. (Jack) Lane, M.D. )
Study ID Numbers:	06-004832
Study First Received:	December 21, 2007
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00587262 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Cochlear
Hearing
High frequency hearing loss

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness

Otorhinolaryngologic Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

ClinicalTrials.gov processed this record on July 02, 2009