Trials / Completed
CompletedNCT01749592
Single-sided Deafness and Cochlear Implants
Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cochlear implant | Surgical implantation of a cochlear implant device |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2018-01-01
- Completion
- 2018-02-08
- First posted
- 2012-12-13
- Last updated
- 2020-09-09
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01749592. Inclusion in this directory is not an endorsement.