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 ]

Pure tone audiometry Speech audiometry Sound localization in both quiet and noise


Original Primary Outcome: Same as current

Current Secondary Outcome: PET scan [ Time Frame: 9 months after intervention ]

[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


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