Single-sided Deafness and Cochlear Implants
- As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual.
- Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear.
- Multicenter, prospective, open, non-randomized clinical trial with 5 patients with right-sided and 5 patients with left-sided sensineural deafness.
- Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG
- Comparison of pre-operative investigations with 10 healthy subjects (age and gender matched control group)
- Cochlea implantation
- Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization Audiometry, PET, EEG, Questionnaires
- Trial with medical device
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants|
- Audiometry [ Time Frame: up to12 months after invention ] [ Designated as safety issue: No ]Pure tone audiometry Speech audiometry Sound localization in both quiet and noise
- PET scan [ Time Frame: 9 months after intervention ] [ Designated as safety issue: Yes ][15O] H2O Positron emission tomography (PET) is performed. The comparison of baseline PET scans and stimulated PET scans will demonstrate task related changes in brain activity
- EEG [ Time Frame: 3, 6 and 12 months after intervention ] [ Designated as safety issue: No ]Resting state EEG and EEG with acoustic paradigm.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Cochlear Implant
Surgical Implantation of a Cochlear Implant
Device: cochlear implant
Surgical implantation of a cochlear implant device
Postlingual single-sided deafness (SSD) is a type of hearing impairment with normal hearing in one ear and severely impaired hearing in the other ear. The condition induces multiple changes of neural plasticity in central auditory pathways. One manifestation reflects an increased common activation of the contralateral and ipsilateral pathways after stimulation of the normal hearing ear which is correlated with an increased activity between the contralateral and ipsilateral hemispheres. As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual. Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear. It is assumed that some changes induced by SSD can be detected only by reversal through a cochlear implant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749592
|Contact: Nicole M Peteremail@example.com|
|Contact: Tobias Kleinjung, MDfirstname.lastname@example.org|
|University Hospital Zurich, Division of Otorhinolaryngology ORL||Recruiting|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Tobias Kleinjung, MD||University Hospital Zurich, Division of Otorhinolaryngology ORL|