Optimization of Cochlear Implant MAP-parameters in Children
NCT ID: NCT03694340
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2018-10-25
2020-06-30
Brief Summary
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At Sahlgrenska University Hospital in Gothenburg, generally, all younger children (0-3 years), the last ten years, had their CI's programmed based on objective measurements. The programming of the CI carried out during the first year after the surgical insertion is done on the foundation of the objective measurements and is generally what the child will live with thereafter. This method also seem to be close to other clinics in Sweden and the rest of the world, however, there are no specific guidelines regarding the how the programming of the CI is to be carried out on small children. To this date there are no studies, to our knowledge, that have confirmed the validity of using these objective measurements and if it is the best for the child. We therefore aim to do a long term follow up on children that have received CI and programmed this way, and study if there would be beneficial to redo the programming when the child is old enough to actively participate.
The aim with this project is evaluate how suitable it is to mainly use objective measurements when programming the cochlear implant and, in addition to this, examine if the children's hearing can be improved if the programming is based on the behavioral measurements of sound when the children are old enough to participate in such. It will examine what happens with the end result if the programming foundation differentiates from one another; if there are any measurable differences in hearing skills.
The result from this project expects to generate knowledge that is highly important for those working with small children receiving CI's, and by extension it will benefit the children that rely on this device in there every day life.
Detailed Description
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For small children who receive CI's at an early age it is not possible to perform measurements based on the child making subjective assessments of how the sound is perceived when the electrical stimulation is altered through the implant. Also, small children cannot judge and report back the quality of the sound. Instead, objective measurements are commonly used since they do not require the active participation of the child, along with observations of the child and how it spontaneously reacts to the sound stimulation. A common objective measurement is to find the lowest level of electrical stimulation required to obtain a response from the auditory nerve, i.e. the electrically evoked action potential (ECAP) threshold. The CI manufacturer Cochlear Ltd has developed an automatic system for this measurement. Based on such measurements, as the automatic ECAP-measurement, the electrical stimulation from the implant can adjusted to the so-called MAP, where the minimum and maximum stimulation levels (T- respectively C-levels) are set for each individual electrode on the implant to create the dynamic range of electrical stimulation. This MAP then becomes the basis for the child's ability to perceive sound.
Clinically, today (at Sahlgrenska University Hospital, Gothenburg, Sweden) a basic programming of the MAP is performed based on ECAP measurements, after which adjustment of only the overall level is carried out based on the child's reactions. However, no subjective measurement is made regarding threshold levels of stimulation through the implant or that the child actually perceives medium sound equally across the different channels. When the child can participate in sound field audiometry, adjustments of the MAP settings are made to get a straight audiogram, but basically, the children continue to use the setting based on the ECAP measurement. Adult patients with acquired deafness receiving CI are managed in a different manner than the children. The programming of the implant for adults is based on subjective measurements of how stimulation via individual electrodes is perceived. By measuring thresholds for individual electrodes, i.e. minimum audible stimulation (T-levels) and levels where stimulation is immediately below unpleasant strong (C-levels), then the MAP is programmed with an individual dynamic range for each electrode.
To our knowledge no previous study have explored how the MAP based on an ECAP measurement endures over time or if a re-programming should be carried out when the child reliably can participate in behavioral measurements, which is about seven years of age in terms of measuring T-levels. Studies have shown that there is a correlation between ECAP-thresholds and T- and C-levels for people who can participate actively. However, the relationship is relatively weak and some researchers have even considered it too weak for ECAP thresholds to be the basis for programming the implant. However, in most clinics, these thresholds are used as a basis for programming CI to small children.
Several of those who work with programming the MAP in small children claims to witness an adaptation in sensitivity of the auditory nerve to the applied stimulation; indicating that the results of the objective measurement could gradually change if there is an alternation in stimulation levels. However, there are no studies at this time that neither confirm nor deny this.
The aim of this project is to investigate and clarify how children who receive CI at an early age should be monitored and to evaluate the objective ECAP measurement as a basis for setting stimulation levels. It also aims to investigate if there is any change in the result of the ECAP measurement after adjustment has been made in the MAP. After completion of the study, the goal is to offer a better and more knowledge-based (re-) habilitation for children who receive CI's, for whom there are currently no definite guidelines for programming and follow-up.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Re-programming of cochlear implant
The cochlear implant is programmed with a new MAP based on behavioral measurements of T- and C-levels and used by the participant for 4 months before follow up.
Re-programming of cochlear implant
New MAP based on behavioral T- and C-levels
Interventions
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Re-programming of cochlear implant
New MAP based on behavioral T- and C-levels
Eligibility Criteria
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Inclusion Criteria
* Received cochlear implant before three years of age
* Have carried out hearing tests with tones and speech recognition
Exclusion Criteria
7 Years
14 Years
ALL
Yes
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Lennart Magnusson, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital, Region Västra Götaland
Locations
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Göteborgs Universitet, Institute of Neuroscience and Physiology, Section of Rehabilitation and Clinical Neuroscienses
Gothenburg, , Sweden
Countries
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References
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Roland JT Jr, Cosetti M, Wang KH, Immerman S, Waltzman SB. Cochlear implantation in the very young child: Long-term safety and efficacy. Laryngoscope. 2009 Nov;119(11):2205-10. doi: 10.1002/lary.20489.
de Vos JJ, Biesheuvel JD, Briaire JJ, Boot PS, van Gendt MJ, Dekkers OM, Fiocco M, Frijns JHM. Use of Electrically Evoked Compound Action Potentials for Cochlear Implant Fitting: A Systematic Review. Ear Hear. 2018 May/Jun;39(3):401-411. doi: 10.1097/AUD.0000000000000495.
Abbas PJ, Brown CJ, Shallop JK, Firszt JB, Hughes ML, Hong SH, Staller SJ. Summary of results using the nucleus CI24M implant to record the electrically evoked compound action potential. Ear Hear. 1999 Feb;20(1):45-59. doi: 10.1097/00003446-199902000-00005.
Botros A, van Dijk B, Killian M. AutoNR: an automated system that measures ECAP thresholds with the Nucleus Freedom cochlear implant via machine intelligence. Artif Intell Med. 2007 May;40(1):15-28. doi: 10.1016/j.artmed.2006.06.003. Epub 2006 Aug 22.
Plant K, Law MA, Whitford L, Knight M, Tari S, Leigh J, Pedley K, Nel E. Evaluation of streamlined programming procedures for the Nucleus cochlear implant with the Contour electrode array. Ear Hear. 2005 Dec;26(6):651-68. doi: 10.1097/01.aud.0000188201.86799.01.
Other Identifiers
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VGRFOU-247791
Identifier Type: -
Identifier Source: org_study_id