Hearing Loss Clinical Trial
Official title:
Cortical Activity in Subjects With Unilateral Cochlear Implants and Preserved Ipsilateral Residual Hearing and the Evolution of Temporal Cortex Changes in New Recipients of Cochlear Implants.
NCT number | NCT02407587 |
Other study ID # | R01997 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | February 27, 2017 |
Verified date | January 2019 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators hope to study patients with 1 cochlear implant and who have had hearing preservation surgery and compare the changes in the brain of these patients with normal hearing patients by doing a scan of the brain when listening to speech. The information investigators collect may help investigators to understand how the brain learns to hear with a cochlear implant and whether it uses the same areas in the brain to listen as in normal hearing patients as well as predict which patients will do well with a cochlear implant as a very specialised operation is needed to insert the cochlear implant in to the ear and is done by very few surgeons in the country. After the operation, patients need several months of teaching to help them learn how to hear through the implant. Having a cochlear implant requires a lot of cooperation and time from the patient and if investigators could understand how the brain learns to hear with a cochlear implant and predict which patients do well and why then we may be able to avoid unnecessary procedures.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 27, 2017 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Mature users of unilateral cochlear implants who have natural preserved hearing in the implanted ear - Healthy volunteers with normal hearing - Right handed Exclusion Criteria: - Individuals with neurological or psychiatric illness - Patients involved in additional drug trials - Pregnant or breast feeding women - Children - Left-handed subjects |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Central Manchester University Hospitals NHS Foundation Trust | Manchester | Manchester (Manchester Borough) |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase our understanding of why outcomes following a cochlear implant are heterogenous. This information may be used to provide targeted rehabilitation for candidates performing poorly with their implants and minimise rejection of the implant. | We anticipate that the recruitment of patients, data collection and analysis would take a maximum of 4 months Study Group PET scans for the mature patients with unilateral cochlear implants and preserved hearing 4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation Control Group 4 states and each state will be repeated 3 times Auditory stimulation Left ear only Auditory stimulation right ear only Binaural auditory stimulation Silence |
1 year | |
Secondary | Combine the data from both of our studies and future studies in order to conduct meta-analysis to investigate further how language is processed in patients with cochlear implants. | 1 year | ||
Secondary | Determine if functional neuroimaging modalities have a future role in the selection process for potential cochlear implant candidates and in predicting outcome for each individual. | 1 year |
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