Study Stopped
unresolved issues with a collaborator.
Neuroplastic Changes Seen in Cochlear Implants With Preserved Hearing
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.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedJanuary 18, 2019
January 1, 2019
2.4 years
September 18, 2014
January 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
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
Study Arms (2)
unilateral cochlear implants
EXPERIMENTALStudy 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
Healthy volunteers
NO INTERVENTION4 states and each state will be repeated 3 times Auditory stimulation Left ear only Auditory stimulation right ear only Binaural auditory stimulation Silence
Interventions
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
Eligibility Criteria
You may qualify if:
- Mature users of unilateral cochlear implants who have natural preserved hearing in the implanted ear
- Healthy volunteers with normal hearing
- Right handed
You may not qualify if:
- Individuals with neurological or psychiatric illness
- Patients involved in additional drug trials
- Pregnant or breast feeding women
- Children
- Left-handed subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Manchester (Manchester Borough), M13 9WL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rohini Aggrawal
Manchester University NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2014
First Posted
April 3, 2015
Study Start
May 1, 2013
Primary Completion
October 1, 2015
Study Completion
February 27, 2017
Last Updated
January 18, 2019
Record last verified: 2019-01