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

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

Sponsors

Lead sponsor: Hospices Civils de Lyon

Source 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

Overall Status Completed
Start Date March 17, 2010
Completion Date March 22, 2016
Primary Completion Date March 22, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cortical brain activation pattern 6 months
Enrollment 43
Condition
Intervention

Intervention type: Other

Intervention name: Positron Emission Tomography (PET)

Intervention type: Other

Intervention name: Electroencephalogram (EEG)

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Location
facility Département d'ORL, Hôpital Edouard Herriot
Location Countries

France

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Profound deaf patients

Arm group type: Other

Description: Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG

Arm group label: Healthy volunteers

Arm group type: Other

Description: Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov