Regulatory and funding strategies to develop a safety study of an auditory brainstem implant in young children who are deaf.
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ABSTRACT:
SUBMITTER: Fisher LM
PROVIDER: S-EPMC4564129 | biostudies-literature | 2015 Sep
REPOSITORIES: biostudies-literature
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Regulatory and funding strategies to develop a safety study of an auditory brainstem implant in young children who are deaf.
Fisher Laurel M LM Eisenberg Laurie S LS Krieger Mark M Wilkinson Eric P EP Shannon Robert V RV
Therapeutic innovation & regulatory science 20150901 5
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Project description:ObjectiveTo determine the safety and feasibility of the auditory brainstem implant (ABI) in congenitally deaf children with cochlear aplasia and/or cochlear nerve deficiency.Study designPhase I feasibility clinical trial of surgery in 10 children, ages 2 to 5 years, over a 3-year period.SettingTertiary children's hospital and university-based pediatric speech/language/hearing center.Intervention(s)ABI implantation and postsurgical programming.Main outcome measure(s)The primary outcome measure is the number and type of adverse events during ABI surgery and postsurgical follow-up, including behavioral mapping of the device. The secondary outcome measure is access to and early integration of sound.ResultsTo date, nine children are enrolled. Five children have successfully undergone ABI surgery and postoperative behavioral programming. Three children were screen failures, and one child is currently undergoing candidacy evaluation. Expected adverse events have been documented in three of the five children who received the ABI. One child experienced a cerebral spinal fluid leak, which resolved with lumbar drainage. One child demonstrated vestibular side effects during device programming, which resolved by deactivating one electrode. One child experienced postoperative vomiting resulting in an abdominal radiograph. Four children have completed their 1-year follow-up and have speech detection thresholds of 30 to 35 dB HL. Scores on the IT-MAIS/MAIS range from 8 to 31 (out of a total of 40), and the children are demonstrating some ability to discriminate between closed-sets words that differ by number of syllables (pattern perception).ConclusionABI surgery and device activation seem to be safe and feasible in this preliminary cohort.
| S-EPMC5266605 | biostudies-literature
Project description:ObjectiveElectrically evoked auditory brainstem responses (EABR) guide placement of the multichannel auditory brainstem implant (ABI) array during surgery. EABRs are also recorded under anesthesia in nontumor pediatric ABI recipients prior to device activation to confirm placement and guide device programming. We examine the influence of anesthesia on evoked response morphology in pediatric ABI users by comparing intraoperative with postoperative EABR recordings.Study designRetrospective review.MethodsSeven children underwent ABI surgery by way of retrosigmoid craniotomy. General anesthesia included inhaled sevoflurane induction and propofol maintenance during which EABRs were recorded to confirm accurate positioning of the ABI. A mean of 7.7 ± 2.8 weeks following surgery, the ABI was activated under general anesthesia or sedation (dexmedetomidine) and EABR recordings were made. A qualitative analysis of intraoperative and postoperative waveform morphology was performed.ResultsSeven subjects (mean age 20.6 months) underwent nine ABI surgeries (seven primary, two revisions) and nine activations. EABRs were observed in eight of nine postoperative recordings. In three cases, intraoperative EABRs during general anesthesia were similar to postoperative EABRs with sedation. In one case, sevoflurane and propofol were used for intra- and postoperative recordings, and waveforms were also similar. In four cases, amplitude and latency changes were observed for intraoperative versus postoperative EABRs.ConclusionSimilarity of EABR morphology in the anesthetized versus sedated condition suggests that anesthesia does not have a large effect on far-field evoked potentials. Changes in EABR waveform morphology observed postoperatively may be influenced by other factors such as movements of the surface array.Level of evidence4 Laryngoscope, 130:507-513, 2020.
| S-EPMC6858482 | biostudies-literature
Project description:A variety of studies have examined ways in which cognitive and social-emotional factors may be linked to and affected by hearing loss, use of cochlear implants (CIs), and sign language. A related domain that largely has been overlooked, however, is personality. This paper reports a study of personality traits and self-efficacy among deaf and hard-of-hearing (DHH; n = 223) college students, with and without CIs, as compared to hearing peers (n = 106). All participants completed (HEXACO) personality trait and self-efficacy inventories; DHH participants also completed a communication questionnaire. Hearing participants scored higher on the personality trait Conscientiousness than both DHH CI users and non-CI users, as well as higher on Openness to Experience compared to DHH CI users. Hearing participants also scored higher on self-efficacy compared to DHH non-CI users. Among DHH non-CI users, greater self-rated sign language skills were associated with higher Extraversion and Agreeableness scores. Among the DHH CI users, earlier sign language acquisition was associated with higher Openness to Experience scores, and earlier cochlear implantation was associated with greater Emotionality scores. Self-efficacy was associated with both better self-rated spoken language skills and a stronger preference for spoken language over sign language use among DHH CI users.
| S-EPMC6146759 | biostudies-other
Project description:Auditory brainstem implants (ABI) can enable hearing sensation through electrical stimulation of the cochlear nucleus. The basic stimulation and signal coding strategies of the ABI are based on those of the cochlear implant. This may not always be optimal, and ABI-specific strategies may be preferred. In a cohort of ten ABI users, we examined the feasibility of measuring local evoked potentials (LEP) via fine-grained stimulation with a forward masking paradigm. We introduce a new baseline-dependent definition of LEP amplitude for analyzing the LEP amplitude growth function to obtain threshold stimulation levels and slope values. The processing of biphasic pulses by the cochlear nucleus and the influence of the leading phase polarity were examined. There were no statistically significant differences in LEP thresholds or slopes between cathodic and anodic leading pulses. LEP thresholds measured with cathodic leading pulses (r = 0.77, t31 = 6.81, p < 0.0001) and anodic leading pulses (r = 0.70, t27 = 45.14, p < 0.0001) correlated significantly with perceptual hearing thresholds. The correlation analysis was impacted by outlier values, especially in the case of LEP thresholds measured with anodic leading pulses. Cathodic leading pulses had significantly shorter LEP peak latencies (t104.8 = 2.63, p < 0.01). These results show that the cathodic leading pulses are superior for eliciting LEPs. We suggest that cathodic leading pulses should be the basis for ABI-specific coding strategies.
| S-EPMC11836220 | biostudies-literature
Project description:IntroductionTinnitus may have a very severe impact on the quality of life. Unfortunately, for many patients, a satisfactory treatment modality is lacking. The auditory brainstem implant (ABI) was originally indicated for hearing restoration in patients with non-functional cochlear nerves, for example, in neurofibromatosis type II. In analogy to a cochlear implant (CI), it has been demonstrated that an ABI may reduce tinnitus as a beneficial side effect. For tinnitus treatment, an ABI may have an advantage over a CI, as cochlear implantation can harm inner ear structures due to its invasiveness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI to investigate its effect on intractable tinnitus.Methods and analysisIn this pilot study, 10 adults having incapacitating unilateral intractable tinnitus and ipsilateral severe hearing loss will have an ABI implanted. The ABI is switched on 6 weeks after implantation, followed by several fitting sessions aimed at finding an optimal stimulation strategy. The primary outcome will be the change in Tinnitus Functioning Index. Secondary outcomes will be tinnitus burden and quality of life (using Tinnitus Handicap Inventory and Hospital Anxiety and Depression Scale questionnaires), tinnitus characteristics (using Visual Analogue Scale, a tinnitus analysis), safety, audiometric and vestibular function. The end point is set at 1 year after implantation. Follow-up will continue until 5 years after implantation.Ethics and disseminationThe protocol was reviewed and approved by the Institutional Review Board of the University Medical Centre Groningen, The Netherlands (METc 2015/479). The trial is registered at www.clinicialtrials.gov and will be updated if amendments are made. Results of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT02630589.Trial statusInclusion of first patient in November 2017. Data collection is in progress. Trial is open for further inclusion. The trial ends at 5 years after inclusion of the last patient.
| S-EPMC6576138 | biostudies-literature
Project description:Cochlear implants (CIs) allow to restore the hearing function in profoundly deaf individuals. Due to the degradation of the stimulus by CI signal processing, implanted individuals with single-sided deafness (SSD) have the specific challenge that the input highly differs between their ears. The present study compared normal-hearing (NH) listeners (N = 10) and left- and right-ear implanted SSD CI users (N = 10 left, N = 9 right), to evaluate cortical speech processing between CI- and NH-ears and to explore for side-of-implantation effects. The participants performed a two-deviant oddball task, separately with the left and the right ear. Auditory event-related potentials (ERPs) in response to syllables were compared between proficient and non-proficient CI users, as well as between CI and NH ears. The effect of the side of implantation was analysed on the sensor and the source level. CI proficiency could be distinguished based on the ERP amplitudes of the N1 and the P3b. Moreover, syllable processing via the CI ear, when compared to the NH ear, resulted in attenuated and delayed ERPs. In addition, the left-ear implanted SSD CI users revealed an enhanced functional asymmetry in the auditory cortex than right-ear implanted SSD CI users, regardless of whether the syllables were perceived via the CI or the NH ear. Our findings reveal that speech-discrimination proficiency in SSD CI users can be assessed by N1 and P3b ERPs. The results contribute to a better understanding of the rehabilitation success in SSD CI users by showing that cortical speech processing in SSD CI users is affected by CI-related stimulus degradation and experience-related functional changes in the auditory cortex.
| S-EPMC9334411 | biostudies-literature
Project description:We characterized the proteome of the auditory brainstem of a chick embryo on embryonic day 13, when apoptosis occurs in auditory nuclei. We identified caspase substrates by searching the peptidome for peptides C-terminal to caspase-typical cleavage sites.
2022-04-01 | PXD030697 | Pride
Project description:BackgroundCochlear implants (CIs) are neural prostheses that have been used routinely in the clinic over the past 25 years. They allow children who were born profoundly deaf, as well as adults affected by hearing loss for whom conventional hearing aids are insufficient, to attain a functional level of hearing. The "modern" CI (i.e., a multi-electrode implant using sequential coding strategies) has yielded good speech comprehension outcomes (recognition level for monosyllabic words about 50% to 60%, and sentence comprehension close to 90%). These good average results however hide a very important interindividual variability as scores in a given patients' population often vary from 5 to 95% in comparable testing conditions. Our aim was to develop a prognostic model for patients with unilateral CI. A novel method of objectively measuring electrical and neuronal interactions using electrical auditory brainstem responses (eABRs) is proposed.Methods and findingsThe method consists of two measurements: 1) eABR measurements with stimulation by a single electrode at 70% of the dynamic range (four electrodes distributed within the cochlea were tested), followed by a summation of these four eABRs; 2) Measurement of a single eABR with stimulation from all four electrodes at 70% of the dynamic range. A comparison of the eABRs obtained by these two measurements, defined as the monaural interaction component (MIC), indicated electrical and neural interactions between the stimulation channels. Speech recognition performance without lip reading was measured for each patient using a logatome test (64 "vowel-consonant-vowel"; VCV; by forced choice of 1 out of 16). eABRs were measured in 16 CI patients (CIs with 20 electrodes, Digisonic SP; Oticon Medical ®, Vallauris, France). Significant correlations were found between speech recognition performance and the ratio of the amplitude of the V wave of the eABRs obtained with the two measurements (Pearson's linear regression model, parametric correlation: r2 = 0.26, p<0.05).ConclusionsThis prognostic model allowed a substantial amount of the interindividual variance in speech recognition scores to be explained. The present study used measurements of electrical and neuronal interactions by eABR to assess patients' bio-electric capacity to use multiple information channels supplied by the implant. This type of prognostic information may be valuable in several ways. On the patient level, it allows customizing of individual treatments. ClinicalTrials.gov Identifier: NCT01805167.
| S-EPMC4858145 | biostudies-literature
Project description:We investigated the effects of electric multi-pulse stimulation on electrically evoked auditory brainstem responses (eABRs). Multi-pulses with a high burst rate of 10,000 pps were assembled from pulses of 45-μs phase duration. Conditions of 1, 2, 4, 8, and 16 pulses were investigated. Psychophysical thresholds (THRs) and most comfortable levels (MCLs) in multi-pulse conditions were measured. Psychophysical temporal integration functions (slopes of THRs/MCLs as a function of number of pulses) were -1.30 and -0.93 dB/doubling of the number of pulses, which correspond to the doubling of pulse duration. A total of 15 eABR conditions with different numbers of pulses and amplitudes were measured. The morphology of eABRs to multi-pulse stimuli did not differ from those to conventional single pulses. eABR wave eV amplitudes and latencies were analyzed extensively. At a fixed stimulation amplitude, an increasing number of pulses caused increasing wave eV amplitudes up to a certain, subject-dependent number of pulses. Then, amplitudes either saturated or even decreased. This contradicted the conventional amplitude growth functions and also contradicted psychophysical results. We showed that destructive interference could be a possible reason for such a finding, where peaks and troughs of responses to the first pulses were suppressed by those of successive pulses in the train. This study provides data on psychophysical THRs and MCLs and corresponding eABR responses for stimulation with single-pulse and multi-pulse stimuli with increasing duration. Therefore, it provides insights how pulse trains integrate at the level of the brainstem.
| S-EPMC7338891 | biostudies-literature
Project description:The frequency-specific tone-evoked auditory brainstem response (ABR) is an indispensable tool in both the audiology clinic and research laboratory. Most frequently, the toneburst ABR is used to estimate hearing thresholds in infants, toddlers, and other patients for whom behavioral testing is not feasible. Therefore, results of the ABR exam form the basis for decisions regarding interventions and hearing habilitation with implications extending far into the child's future. Currently, responses are elicited by periodic sequences of toneburst stimuli presented serially to one ear at a time, which take a long time to measure multiple frequencies and intensities, and provide incomplete information if the infant wakes up early. Here, we describe a new method, the parallel ABR (pABR), which uses randomly timed toneburst stimuli to simultaneously acquire ABR waveforms to five frequencies in both ears. Here, we describe the pABR and quantify its effectiveness in addressing the greatest drawback of current methods: test duration. We show that in adults with normal hearing the pABR yields high-quality waveforms over a range of intensities, with similar morphology to the standard ABR in a fraction of the recording time. Furthermore, longer latencies and smaller amplitudes for low frequencies at a high intensity evoked by the pABR versus serial ABR suggest that responses may have better place specificity due to the masking provided by the other simultaneous toneburst sequences. Thus, the pABR has substantial potential for facilitating faster accumulation of more diagnostic information that is important for timely identification and treatment of hearing loss.
| S-EPMC6852359 | biostudies-literature