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Completed

NCT Number: NCT03117413

Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.

Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

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Key information

Conditions

Profound Hearing Impairment Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Toulouse - Hôpital Purpan, Toulouse, France

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About this study

Cochlear implantation is the most efficient method to restore hearing in deaf patients. However, about 2/3 of patients have some residual hearing and these patients usually combine two types of auditory information (electrical and acoustical). It is important to know how the brain is processing during two distinct stimulations and how it is related to the auditory level of performance.

Patients and controls will undergo a positron emission tomography scan brain imaging session during a simplified voice/non-voice discrimination task. For each tasks and brain imaging sessions, patients will be stimulated either with the non-implanted ear (acoustical stimulation), the cochlear implant (electrical stimulation) and using both modalities in a binaural condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cochlear implantation>3 months
  • signature of informed consent
  • affiliation to social service.

Exclusion criteria

  • associated neurological disorder
  • protected subjects
  • epilepsy episodes
  • psychotropic medication
  • pregnancy

Treatment and study plan

Positron emission tomography scan

Other
  • Binaural hearing assessments: speech recognition in noise and sound source localization
  • Voice perception assessment: voice/non-voice discrimination task, free categorization task
  • Positron emission tomography examinations under ecological auditory stimuli (voice/non-voice discrimination task)

Primary outcomes

  1. Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.

    Time frame: Day 1

    Prior to the imaging session, patients performed two human voice interpretation tests. link between temporal activations and performances obtained in binaural integration tasks in the patient group.

Secondary outcomes

  1. differences in auditory brain activation.

    Time frame: Week 3 - Week 5

    Auditory brain activation when the better ear is acoustically stimulated in asymmetric hearing loss subjects and when one ear is stimulated in normal hearing subjects.

  2. Performance level and the pattern of brain activation.

    Time frame: Week 3 - Week 5

    Acoustical or electrical stimulation in asymmetric hearing loss cochlear implanted subjects.

  3. the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.

    Time frame: Week 3 - Week 5

    Electrical and acoustical stimulation will be used.

  4. link between binaural hearing performances and auditory brain activation in the binaural condition.

    Time frame: Week 3 - Week 5

    For the group of cochlear implanted subjects with asymmetric hearing loss.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Centre de recherche Cerveau et Cognition (CERCO)

Registry information

Official study title

Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation

Acronym: UniTEP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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