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Evaluation of a Bio-inspired Coding Strategy for Cochlear Implant Users (EBCS)

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ClinicalTrials.gov Identifier: NCT03726684
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date October 31, 2018
Actual Study Start Date  ICMJE July 2, 2018
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
Melody contour identification (MCI) test (% correct) [ Time Frame: 6 months ]
In the MCI test, five different melody contour patterns with three tones in each pattern are presented in a five alternative forced choice paradigm. The complex tones are synthesized to resemble a clarinet musical instrument. Three separations of fundamental tone frequency varying from one to three semitones are used to vary the difficulties for pattern identification. Every pattern is repeated 10 times in random order which amounts to a total of 150 melody contour presentations per condition. Overall percent correct results and percent correct results for each of the five patterns are determined for the reference and the intervention conditions. Tests are performed with the conventional ACE coding strategy (reference condition) and the bioinspired coding strategy whose parameters are determined from electrophysiological measures of sound-evoked neural responses (intervention condition).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • Adaptive Oldenburg sentence test (OLSA) in noise (SRT in dB) [ Time Frame: 6 months ]
    The Adaptive Oldenburg sentence test (OLSA) in noise is used to evaluate speech intelligibility in a noisy environment. The noise level is kept constant at 65 dB sound pressure Level (SPL, in dB) and the speech level is adjusted adaptively to determine the speech reception threshold (SRT, in dB, for 50% speech intelligibility in noise). Lower SRT values indicate better speech recognition in noise. Tests are performed with the conventional ACE coding strategy (reference condition) and the bioinspired coding strategy whose parameters are determined from electrophysiological measures of sound-evoked neural responses (intervention condition).
  • Time constants (usec) of recovery functions of electrically stimulated auditory nerve fibers, measured by electrically evoked compound action potential (ECAP) [ Time Frame: 6 months ]
    Time constants of recovery functions of electrically stimulated auditory nerve fiber groups can be assessed by ECAP measures through the cochlear implant for various electrode positions. Series of two stimulation pulses are presented whereby the interval between the two pulses is increased from 100 usec to 10'000 usec. The nerve response amplitude grows with increasing interpulse delay from zero up to a saturation level.
  • Width of spread of excitation function (in mm) of electrically evoked compound action potential (ECAP) measures [ Time Frame: 6 months ]
    Spread of excitation (SOE) is measured with a fixed probe and varying masker electrodes along the electrode array. The width of exponentially fitted SOE curves (in mm) is the main measurement parameter. Outcome variations depend on the amount and distribution of remaining auditory nerve fibers and the geometrical properties of the implanted electrode array relative to the anatomical situation of the patient's inner ear.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Bio-inspired Coding Strategy for Cochlear Implant Users
Official Title  ICMJE Evaluation of a Bio-inspired Coding Strategy for Cochlear Implant Users
Brief Summary

This study will determine the facilitation, refractoriness and spatial spread effects of auditory nerve fiber responses to electrical stimulation via a cochlear implant.

The performance of CI users in melody contour and speech recognition in noise tests with their own clinical sound processor and a MATLAB implementation of their coding strategy will be compared and a bioinspired coding strategy will be evaluated in comparison with the conventional ACE coding strategy.

Detailed Description

The advanced combination encoder (ACE) strategy, one of the most widely used clinical speech processing strategies available to cochlear implant (CI) users, attempts to optimize transmission of input acoustic signals, but does not explicitly consider the auditory nerve fibers' (ANFs) capacity for conveying this information. The ACE strategy decomposes temporal frames of the incoming sound signal into frequency bands with a bank of band-pass Fast Fourier Transform (FFT) filters. The temporal envelopes in each band are then extracted and typically eight to ten bands with the highest energy content are selected to amplitude modulate the biphasic pulses. This selection is performed irrespective of the ANFs responses to the electrical stimulation. However, some studies have shown that temporal response properties of ANFs impose limitations for electrical stimulation. Apart from that, the degree of spread of neural excitation which is typically larger than in the acoustic case, may result in responses which can diminish information provided on the individual channels. Thus, a coding strategy taking into account temporal properties of ANFs as well as spatial spread of the electric field could be beneficial for CI users.

One of the prominent temporal characteristics of ANFs in response to the electrical stimulation is refractoriness. This phenomenon can be defined as a reduction in the excitability of ANFs immediately following an action potential and has been observed in CI recipients via measuring the electrically evoked compound action potential (ECAP). The refractory period can be divided into an absolute refractory period (ARP) during which the auditory nerve is incapable of responding to the following pulse and a relative refractory period (RRP) during which a response from the neuron is possible under specific circumstances. Refractoriness can impose limitations on the maximum stimulation rate of CIs since ANFs cannot respond to a stimulus presented during the ARP.

Apart from refractoriness, an ongoing high rate pulse train produces spike rate adaptation (SRA) in ANFs in which the neurons progressively lose their ability to respond to every pulse. This decrement in neural excitability is even larger than can be explained by refractoriness. Animal studies of ANFs at high rate pulse trains have shown SRA and adaptation has also been observed in the ECAP amplitude of human CI users in which the amplitude decreased as the stimulation rate increased. In parallel to spike rate adaptation, accommodation can contribute to the spike rate decrement. Accommodation reduces excitability for the second pulse (probe) response when there is a subthreshold response to the first pulse (masker) and the masker-probe interval (MPI) is large enough to allow the membrane potential to decay back near or below the resting potential. Accommodation in addition to SRA is considered as reduction in the excitability of ANFs and its effect accumulates over sequential non-spiking responses.

Electrical stimulation of ANFs in animals with pairs of pulses has also shown facilitation which is defined as an increase in nerve excitability caused by sub-threshold stimulation in short intervals. Apart from animal studies, the facilitation effect has also been observed in human CI recipients. Facilitation happens when the neuron does not respond to the first pulse, but if the membrane potential remains near the threshold long enough, the second pulse can produce a response. It was shown that facilitation is more evident at a low MPI and for a masker with an intensity equal or less than that of a probe. Although the facilitation effect was observed in human CI users, systematic ECAP measurement to quantify this effect were not yet performed. Thus, neural response telemetry (NRT) measurements with negative masker offset and short MPIs need to be done to determine a non-monotonic behaviour of facilitation and confirm the predictions by Cohen in his model simulations.

Apart from ANFs temporal considerations, electrical current spreads out widely along the cochlea and excites a wide range of populations of ANFs which leads to a decrease in the selectivity and the number of effective channels. Thus, spatial spread of the electric field has a major impact on the spectral resolution of CI users and decreases the excitability of the affected ANF population.

In the planned study refractoriness, spatial spread and facilitation effects will first be determined from NRT measurements with CI participants. Then, all the aforementioned phenomena are integrated in a bio-inspired coding strategy for a better selection of channels with highest energy content. This new strategy will be compared to the conventional ACE coding strategy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single center, single-armed, parallel design with four laboratory sessions for CI subjects
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hearing Loss, Complete
Intervention  ICMJE Device: Coding strategy for cochlear implants
Comparison of two variations of a coding strategy based on electrophysiological objective measures with standard reference coding strategy
Other Name: Nucleus Cochlear Implant System
Study Arms  ICMJE Experimental: Coding strategy for cochlear implants
Measure neural responses of cochlear implant recipient Use measured values of refractoriness, spread of excitation and facilitation as parameters for a bioinspired coding strategy perform listening tests to compare new coding strategy with standard clinical coding strategy
Intervention: Device: Coding strategy for cochlear implants
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2018
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • having Nucleus System 4, System 5, System 6 or System 7 sound processor
  • having 20 or more active electrodes
  • using one of these implant types: System 4, System 5, System 6, System 7
  • using ACE coding strategy
  • speech recognition score of at least 70% on Oldenburg Speech Test (OLSA) in quiet
  • ability to perform an adaptive speech recognition test in noise
  • experience with their CI for at least six months
  • ability for speech understanding in the presence of competing noise without any assistance from lip-reading
  • ability to hear differences between musical notes at least for the easiest condition (3 semitones difference between successive notes in a pattern)
  • ability to provide subjective feedback in a certain listening situation
  • proficiency in reading and writing in German

Exclusion Criteria:

  • Acute inflammation or pain in head-/neck area
  • Dizziness
  • Other known illness which would prevent regular participation in test sessions
  • Age of participants < 18 years
  • Age of participants > 80 years
  • Non-standard clinical sound processor program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Andrea Kegel, MA +41 44 255 5808 andrea.kegel@usz.ch
Contact: Sonia Tabibi, MSc +41 44 255 5808 sonia.tabibi@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726684
Other Study ID Numbers  ICMJE EBCS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Norbert Dillier, PhD University of Zurich
PRS Account University of Zurich
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP