Clinical Trial: Single-sided Deafness and Cochlear Implants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
Brief Summary:
- 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
Detailed Summary: 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.
Sponsor: University of Zurich
Current Primary Outcome: Audiometry [ Time Frame: up to12 months after invention ]
Original Primary Outcome: Same as current
Current Secondary Outcome: PET scan [ Time Frame: 9 months after intervention ]
Original Secondary Outcome: Same as current
Information By: University of Zurich
Dates:
Date Received: December 11, 2012
Date Started: December 2012
Date Completion: September 2017
Last Updated: July 4, 2016
Last Verified: July 2016