Hearing and Structure Preservation Via ECochG

Official title

Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide

Overview

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Detailed description

Cochlear implantation is a highly effective method of rehabilitating hearing in individuals with severe to profound hearing loss. One current hurdle to optimising hearing outcomes following cochlear implantation is the unavoidable trauma caused to the inner ear during implant surgery. This damage can mean residual hearing that would remain valuable following implantation is lost. Various approaches have been trialed to preserve hearing during implantation surgery, modifying implantation technique and administering steroids. Electrocochleography (ECochG) is a monitoring technique that can be used during electrode insertion to record inner ear structural integrity and function.

The PRESERVE trial is an international, multi-centre, randomised controlled trial. The trial will randomly allocate adult cochlear implant recipients to undergo implantation surgery either with ECochG-guidance, or via the standard approach without guidance. Participants will be blinded, meaning they will not know which group they will be allocated to. Where ECochG is used, evidence of damage during insertion detected with the monitoring will trigger the surgeon to follow a corrective pathway. All other aspects of surgery and post operative care will follow standard clinical pathways for both groups.

Participants will have their natural hearing measured preoperatively, and 3- and 6-months following implant activation. The change in natural hearing thresholds at different frequencies, and the degree of hearing preservation will then be calculated and compared between the standard surgery and ECochG-guided group. Using their cochlear implant, understanding of speech will also be measured and compared between groups. In addition, participants will undergo a second CT scan following implantation surgery, and this will be compared to the routine pre-operative imaging to assess both the location of the implant electrode, and structural preservation of the cochlear. Throughout the study participants will remain under the care of their routine medical team.

Interventions

• Procedure ECochG monitored CI surgery incl. corrective action guide
  Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
• Procedure Routine CI surgery without ECochG monitoring
  Routine CI surgery with access to ECochG monitoring by surgeon

Primary outcome measures

• Hearing Preservation [Time frame: From pre-operative to 6 months post-operative]

Secondary outcome measures (2)

• Structure Preservation [Time frame: 1 month post-operative]
• Speech perception [Time frame: From pre-operative to 6 months post-operative]

Eligibility criteria

Inclusion criteria

• Aged 18 years of age or older
• Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation
• Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted
• Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted
• Less than 15 years of severe to profound deafness on the implant ear prior to surgery
• Post-lingually acquired hearing loss in the ear to be implanted
• Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted
• Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array
• Listed for cochlear implant surgery under general anaesthesia
• Fluent in local language
• Given informed consent to participate in the study

Exclusion criteria

• Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
• Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
• Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections
• Diagnosis of auditory spectrum neuropathy disorder
• Deafness due to lesions of the acoustic nerve or central auditory pathway
• Deafened by meningitis
• Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)
• Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear > 30 dB HL and ≤ 55 dB HL)
• History of previous cochlear implantation/re-implantation on either ear
• Any contraindications to computed tomography (CT) scans
• Concurrent participation in other cochlear implant related studies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Belgium · 1 center

• Universitair Ziekenhuis Gent — Ghent

France · 1 center

• Le Centre Hospitalier Régional Universitaire de Tours — Tours

Germany · 1 center

• Universitätsklinikum Freiburg Klinik — Freiburg im Breisgau

Italy · 1 center

• Ospedale Martini — Torino

Poland · 1 center

• World Hearing Center — Warsaw

Spain · 1 center

• Hospital Universitario Clinico San Cecilio — Granada

United Kingdom · 1 center

• Cambridge University Hospitals NHS Foundation Trust — Cambridge

Publications

• Bester C, Collins A, Razmovski T, Weder S, Briggs RJ, Wei B, Zakaria AF, Gerard JM, Mitchell-Innes A, Tykocinski M, Kennedy R, Iseli C, Dahm M, Ellul S, O'Leary S. Electrocochleography triggered intervention successfully preserves residual hearing during cochlear implantation: Results of a randomised clinical trial. Hear Res. 2022 Dec;426:108353. doi: 10.1016/j.heares.2021.108353. Epub 2021 Sep 20 PMID 34600798
• Buechner A, Bardt M, Haumann S, Geissler G, Salcher R, Lenarz T. Clinical experiences with intraoperative electrocochleography in cochlear implant recipients and its potential to reduce insertion trauma and improve postoperative hearing preservation. PLoS One. 2022 Apr 22;17(4):e0266077. doi: 10.1371/journal.pone.0266077. eCollection 2022. PMID 35452461
• Carlson ML, Driscoll CL, Gifford RH, Service GJ, Tombers NM, Hughes-Borst BJ, Neff BA, Beatty CW. Implications of minimizing trauma during conventional cochlear implantation. Otol Neurotol. 2011 Aug;32(6):962-8. doi: 10.1097/MAO.0b013e3182204526. PMID 21659922
• Dalbert A, Sim JH, Gerig R, Pfiffner F, Roosli C, Huber A. Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. Otol Neurotol. 2015 Aug;36(7):1172-80. doi: 10.1097/MAO.0000000000000768. PMID 25839980
• Koka K, Riggs WJ, Dwyer R, Holder JT, Noble JH, Dawant BM, Ortmann A, Valenzuela CV, Mattingly JK, Harris MM, O'Connell BP, Litvak LM, Adunka OF, Buchman CA, Labadie RF. Intra-Cochlear Electrocochleography During Cochear Implant Electrode Insertion Is Predictive of Final Scalar Location. Otol Neurotol. 2018 Sep;39(8):e654-e659. doi: 10.1097/MAO.0000000000001906. PMID 30113557
• Giardina CK, Brown KD, Adunka OF, Buchman CA, Hutson KA, Pillsbury HC, Fitzpatrick DC. Intracochlear Electrocochleography: Response Patterns During Cochlear Implantation and Hearing Preservation. Ear Hear. 2019 Jul/Aug;40(4):833-848. doi: 10.1097/AUD.0000000000000659. PMID 30335669
• Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163. PMID 23446225
• Lenarz T, Timm ME, Salcher R, Buchner A. Individual Hearing Preservation Cochlear Implantation Using the Concept of Partial Insertion. Otol Neurotol. 2019 Mar;40(3):e326-e335. doi: 10.1097/MAO.0000000000002127. PMID 30741914

Identifiers

NCT: NCT06268340 · ABIntl-23-25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗