Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
1 other identifier
interventional
43
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2016
CompletedFirst Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedDecember 19, 2025
December 1, 2025
6 years
August 11, 2016
December 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cortical brain activation pattern
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
Study Arms (2)
Profound deaf patients
OTHERProfound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG
Healthy volunteers
OTHERHealthy volunteers: Cortical brain activation pattern obtained by PET and EEG
Interventions
Eligibility Criteria
You may qualify if:
- \- profoundly deaf patients with bilateral cochlear implants
You may not qualify if:
- 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
- \- normal hearing subjects
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Département d'ORL, Hôpital Edouard Herriot
Lyon, 69437, France
Related Publications (1)
Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
PMID: 35943235RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2016
First Posted
September 16, 2016
Study Start
March 17, 2010
Primary Completion
March 22, 2016
Study Completion
March 22, 2016
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share