Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

August 26, 2019 updated by: Hospices Civils de Lyon
The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon cedex 03, France, 69437
        • Département d'ORL, Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria for patients:

- profoundly deaf patients with bilateral cochlear implants

Exclusion criteria for patients:

  • post-operative complications
  • incomplete surgical insertion of one of the cochlear implant
  • age under 18 years
  • non-compliant patient
  • pregnant woman or woman with no efficient contraception method
  • informed consent not signed
  • no health insurance

Inclusion criteria for control

- normal hearing subjects

Exclusion criteria control

  • normal hearing subject
  • subject under 18 years old
  • unilateral or bilateral hearing loss
  • non-compliant subject
  • pregnant woman or woman with no efficient contraception method
  • informed consent not signed
  • no health insurance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Profound deaf patients
Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG
Other: Positron Emission Tomography (PET)
Other: Electroencephalogram (EEG)
Other: Healthy volunteers
Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG
Other: Positron Emission Tomography (PET)
Other: Electroencephalogram (EEG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical brain activation pattern
Time Frame: 6 months
Cortical brain activation pattern obtained by PET or EEG cartography. Activation pattern will be compared between normal hearing subjects and deaf adults with bilateral cochlear implants
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2010

Primary Completion (Actual)

March 22, 2016

Study Completion (Actual)

March 22, 2016

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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