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

Civil Hospices of Lyon

Status: Completed

Conditions: Deafness

Treatments: Other: Positron Emission Tomography (PET); Other: Electroencephalogram (EEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02904187

2008-542

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Profound deaf patients

Other group

Description:

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

Treatment:

Other: Electroencephalogram (EEG)

Other: Positron Emission Tomography (PET)

Healthy volunteers

Other group

Description:

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

Treatment:

Other: Electroencephalogram (EEG)

Other: Positron Emission Tomography (PET)