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

Not Applicable

Completed

• Conditions: Deafness
• Interventions: Other: Positron Emission Tomography (PET); Other: Electroencephalogram (EEG)

• Registration Number: NCT02904187
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Primary Completion: 2016-03-22
• Study Completion: 2016-03-22
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cortical brain activation pattern	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

Trial Locations

Locations (1)

Département d'ORL, Hôpital Edouard Herriot; 🇫🇷 Lyon cedex 03, France