The VertiGO! Trial protocol: A prospective, single-center, patient-blinded study to evaluate efficacy and safety of prolonged daily stimulation with a multichannel vestibulocochlear implant prototype in bilateral vestibulopathy patients.

BACKGROUND: A combined vestibular (VI) and cochlear implant (CI) device, also known as the vestibulocochlear implant (VCI), was previously developed to restore both vestibular and auditory function. A new refined prototype is currently being investigated. This prototype allows for concurrent multichannel vestibular and cochlear stimulation. Although recent studies showed that VCI stimulation enables compensatory eye, body and neck movements, the constraints in these acute study designs prevent them from creating more general statements over time. Moreover, the clinical relevance of potential VI and CI interactions is not yet studied. The VertiGO! Trial aims to investigate the safety and efficacy of prolonged daily motion modulated stimulation with a multichannel VCI prototype. METHODS: A single-center clinical trial will be carried out to evaluate prolonged VCI stimulation, assess general safety and explore interactions between the CI and VI. A single-blind randomized controlled crossover design will be implemented to evaluate the efficacy of three types of stimulation. Furthermore, this study will provide a proof-of-concept for a VI rehabilitation program. A total of minimum eight, with a maximum of 13, participants suffering from bilateral vestibulopathy and severe sensorineural hearing loss in the ear to implant will be included and followed over a five-year period. Efficacy will be evaluated by collecting functional (i.e. image stabilization) and more fundamental (i.e. vestibulo-ocular reflexes, self-motion perception) outcomes. Hearing performance with a VCI and patient-reported outcomes will be included as well. DISCUSSION: The proposed schedule of fitting, stimulation and outcome testing allows for a comprehensive evaluation of the feasibility and long-term safety of a multichannel VCI prototype. This design will give insights into vestibular and hearing performance during VCI stimulation. Results will also provide insights into the expected daily benefit of prolonged VCI stimulation, paving the way for cost-effectiveness analyses and a more comprehensive clinical implementation of vestibulocochlear stimulation in the future. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04918745. Registered 28 April 2021.

Optimizing vestibular implant electrode positioning using fluoroscopy and intraoperative CT imaging.

PURPOSE:  Vestibular implant electrode positioning close to the afferent nerve fibers is considered to be key for effective and selective electrical stimulation. However, accurate positioning of vestibular implant electrodes inside the semicircular canal ampullae is challenging due to the inability to visualize the target during the surgical procedure. This study investigates the accuracy of a new surgical protocol with real-time fluoroscopy and intraoperative CT imaging, which facilitates electrode positioning during vestibular implant surgery. METHODS:  Single-center case-controlled cohort study with a historic control group at a tertiary referral center. Patients were implanted with a vestibulocochlear implant, using a combination of intraoperative fluoroscopy and cone beam CT imaging. The control group consisted of five patients who were previously implanted with the former implant prototype, without the use of intraoperative imaging. Electrode positioning was analyzed postoperatively with a high-resolution CT scan using 3D slicer software. The result was defined as accurate if the electrode position was within 1.5 mm of the center of the ampulla. RESULTS: With the new imaging protocol, all electrodes could be positioned within a 1.5 mm range of the center of the ampulla. The accuracy was significantly higher in the study group with intraoperative imaging (21/21 electrodes) compared to the control group without intraoperative imaging (10/15 electrodes), (p = 0.008). CONCLUSION:  The combined use of intraoperative fluoroscopy and CT imaging during vestibular implantation can improve the accuracy of electrode positioning. This might lead to better vestibular implant performance.

The resilience of the inner ear-vestibular and audiometric impact of transmastoid semicircular canal plugging.

BACKGROUND: Certain cases of superior semicircular canal dehiscence or benign paroxysmal positional vertigo can be treated by plugging of the affected semicircular canal. However, the extent of the impact on vestibular function and hearing during postoperative follow-up is not known. OBJECTIVE: To evaluate the evolution of vestibular function and hearing after plugging of a semicircular canal. METHODS: Six patients underwent testing before and 1 week, 2 months, and 6 months after plugging of the superior or posterior semicircular canal. Testing included caloric irrigation test, video Head Impulse Test (vHIT), cervical and ocular Vestibular Evoked Myogenic Potentials (VEMPs) and audiometry. RESULTS: Initially, ipsilateral caloric response decreased in all patients and vHIT vestibulo-ocular reflex (VOR) gain of each ipsilateral semicircular canal decreased in 4/6 patients. In 4/6 patients, postoperative caloric response recovered to > 60% of the preoperative value. In 5/6 patients, vHIT VOR gain was restored to > 85% of the preoperative value for both ipsilateral non-plugged semicircular canals. In the plugged semicircular canal, this gain decreased in 4/5 patients and recovered to > 50% of the preoperative value. Four patients preserved cervical and ocular VEMP responses. Bone conduction hearing deteriorated in 3/6 patients, but recovered within 6 months postoperatively, although one patient had a persistent loss of 15 dB at 8 kHz. CONCLUSION: Plugging of a semicircular canal can affect both vestibular function and hearing. After initial deterioration, most patients show recovery during follow-up. However, a vestibular function loss or high-frequency hearing loss can persist. This stresses the importance of adequate counseling of patients considering plugging of a semicircular canal.

Prospective Analysis of an Evidence-Based Symptom Set in Superior Canal Dehiscence Syndrome.

INTRODUCTION: Superior canal dehiscence syndrome (SCDS) is characterized by a defect in the bone overlying the superior semicircular canal. This third mobile window generates an abnormal low-impedance pathway for sound/pressure transmission into the inner ear resulting in the characteristic symptoms. OBJECTIVE: To perform a prospective analysis of symptoms in patients with SCDS. METHODS: An aggregated symptom set was studied prospectively and compared with a healthy control group. The 31 items inquired about the presence and severity of symptoms. Initial comparison between both groups was performed using the Kolmogorov-Smirnov test and nonparametric Mann-Whitney U test. For analysis of the internal consistency, the Cronbach's alpha coefficient was determined. Finally, the prevalence of symptoms obtained in the present study was compared to the prevalence of symptoms obtained as part of a recent retrospective systematic review. RESULTS: Responses from the 29 patients with SCDS in the case group and the 58 healthy controls were not normally distributed. Those with SCDS had a higher prevalence and more severe symptoms for almost all items. The Cronbach's alpha coefficient of 0.969 indicates an excellent internal consistency. The prospective prevalence of most symptoms was higher than the retrospective prevalence reported earlier. CONCLUSIONS: SCDS causes a variety of vestibular and auditory symptoms. This prospective study demonstrates that their prevalence and severity are higher than reported previously. This symptom set demonstrates excellent internal consistency and will serve as a foundation toward developing a disease-specific patient-reported outcome measure for SCDS. LEVEL OF EVIDENCE: NA.

Impact of cochlear implantation on the function of the three semicircular canals.

OBJECTIVE: To assess the effect of cochlear implantation on the function of the semicircular canals (SCC) and on experienced vestibular symptoms. Second, to determine the relation between vestibular test results. DESIGN: Retrospective cohort study assessing absolute and categorised results of caloric irrigation test, video Head Impulse Test (vHIT) and Dizziness Handicap Inventory (DHI) before and after cochlear implantation.Study sample: 192 patients, aged ≥7 years old, without preoperative areflexia. RESULTS: Mean maximum slow phase velocity decreased with 3.1°/s and 4.7°/s for warm and cold caloric irrigation respectively. About 37.4% of the patients deteriorated one or more categories on caloric testing. Complete caloric postoperative areflexia was found in 6.2%. Mean vHIT gain decreased with 0.06, 0.04 and 0.05 for anterior, lateral and posterior SCC, respectively. Seven patients (7.7%) acquired an abnormal gain value for the anterior SCC. Only mean score on DHI's physical subdomain rose significantly (1.4 points). Overall, 9.0% of the patients deteriorated one or two categories on DHI. Only few weak correlations were found between caloric test, vHIT and DHI shifts. CONCLUSIONS: Although mean objective and subjective-physical vestibular deteriorations were significant, its clinical impact seems limited. However, 9% of patients experience vestibular deterioration, thus, advocate assessment. Vestibular test results show no or merely weak mutual correlations.

Hearing Results of Surgery for Acquired Atresia of the External Auditory Canal.

OBJECTIVE: To evaluate short- and long-term hearing results of surgery for acquired atresia of the external auditory canal (EAC) in a large patient cohort and to define preoperative audiometric conditions useful for patient counseling. STUDY DESIGN: Retrospective cohort study. SETTING: Academic tertiary referral center. PATIENTS: Seventy-eight ears from 72 patients with postinflammatory acquired atresia of the EAC who underwent canal- and meatoplasty were included. Patients with involvement of the ossicular chain, (syndromic) external ear malformations, or congenital aural atresia were excluded. INTERVENTION: Canal- and meatoplasty. MAIN OUTCOME MEASURES: Mean pure-tone averages of thresholds at 0.5, 1, 2, and 3 kHz (PTA0.5,1,2,3) for air conduction (AC), bone conduction, and air-bone gap (ABG) were calculated preoperatively and at short-term (≤0.55 yr) and long-term follow-up (>0.55 yr). Additionally, the numbers of ears with a closed ABG ≤10 dB and ≤20 dB, and with Social hearing (defined as: AC PTA0.5,1,2,3 ≤35 dB) were assessed. RESULTS: At short-term follow-up AC PTA0.5,1,2,3 improved by 18 dB. Social hearing was obtained in 81% of the ears. Postoperatively, 35% of the ears had a closed ABG ≤10 dB, 83% was closed ≤20 dB. During follow-up, significant deterioration of 5 to 7 dB occurred for AC thresholds at 0.25, 0.5, and 1 kHz. CONCLUSIONS: Surgery for acquired atresia of the EAC is often beneficial. This study suggests overall advantageous surgery when the preoperative indication criteria ABG PTA0.5,1,2,3 >20 dB and AC PTA0.5,1,2,3 >35 dB are applied.

Drafting a Surgical Procedure Using a Computational Anatomy Driven Approach for Precise, Robust, and Safe Vestibular Neuroprosthesis Placement-When One Size Does Not Fit All.

OBJECTIVE: To design and evaluate a new vestibular implant and surgical procedure that should reach correct electrode placement in 95% of patients in silico. DESIGN: Computational anatomy driven implant and surgery design study. SETTING: Tertiary referral center. PARTICIPANTS: The population comprised 81 patients that had undergone a CT scan of the Mastoid region in the Maastricht University Medical Center. The population was subdivided in a vestibular implant eligible group (28) and a control group (53) without known vestibular loss. INTERVENTIONS: Canal lengths and relationships between landmarks were calculated for every patient. The relationships in group-anatomy were used to model a fenestration site on all three semicircular canals. Each patient's simulated individual distance from the fenestration site to the ampulla was calculated and compared with the populations average to determine if placement would be successful. MAIN OUTCOME MEASURES: Lengths of the semicircular canals, distances from fenestration site to ampulla (intralabyrinthine electrode length), and rate of successful electrode placement (robustness). RESULTS: The canal lengths for the lateral, posterior, and superior canal were respectively 12.1 mm ±â€Š1.07, 18.8 mm ±â€Š1.62, and 17.5 mm ±â€Š1.23, the distances from electrode fenestration site to the ampulla were respectively 3.73 mm ±â€Š0.53, 9.02 mm ±â€Š0.90, and 5.31 mm ±â€Š0.73 and electrode insertions were successful for each respective semicircular canal in 92.6%, 66.7%, and 86.4% of insertions in silico. The implant electrode was subsequently revised to include two more electrodes per lead, resulting in a robustness of 100%. CONCLUSIONS: The computational anatomy approach can be used to design and test surgical procedures. With small changes in electrode design, the proposed surgical procedure's target robustness was reached.