VertiGO! - Get up and GO! With the Vestibular Implant

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jun 1, 2021

Keywords

ClinConnect Summary

The VertiGO! trial is a study exploring a new treatment option for individuals with a condition called bilateral vestibular loss, which can lead to severe balance issues and difficulties with vision stability. In this trial, 13 participants who have both vestibular loss and significant hearing loss will receive a special device that combines a cochlear implant with a vestibular implant. This device aims to stimulate both hearing and balance nerves to help improve patients' overall function. Participants will use this device in a hospital setting for three weeks while being closely monitored.

To qualify for the trial, participants must be adults aged 18 and older with chronic balance problems and specific test results indicating vestibular dysfunction. They must also be able to communicate in Dutch and be willing to follow the study protocols, which include avoiding certain medications and activities during the trial period. Throughout the study, researchers will gather information on how safe and effective this combined device is, as well as develop a rehabilitation program to support participants in adapting to the device. This trial represents an important step in finding new ways to treat vestibular disorders that currently have no effective treatments.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Chronic vestibular syndrome being presented by disabling symptoms of postural imbalance and/or impaired image stabilization (e.g. oscillopsia)
• 2. Reduced or absent bilateral VOR function based on at least one of the tests below meeting criteria A, with the other tests meeting criteria B:
• • Criteria A: Caloric response: Each side ≤6°/sec, vHIT gain: Bilateral horizontal SCC ≤ 0.6 AND Bilateral vertical SCC \<0.7, Rotatory chair gain: ≤ 0.1 (0.1 Hz)
• • Criteria B: Caloric response: Each side \<10°/sec, vHIT gain: 2 Bilateral SCC \<0.7, Rotatory chair gain: ≤ 0.2 (0.1 Hz)
• • 3. Onset of bilateral vestibular loss after the age of 2
• • 4. Vestibular dysfunction from a peripheral origin or idiopathic BV
• • 5. Patent vestibular end-organ (judged by CT)
• • 6. Vestibular function and symptoms have not recovered beyond inclusion criteria within 6 months from onset of symptoms including a 3 month rehabilitation program off vestibular suppressant medications
• • 7. Meeting CI-candidacy in ear to implant with CVI
• • 8. Agreed to receive a MED-EL CVI implant with MED-EL sound processor
• • 9. Capacitated adults ≥ 18 years
• • 10. Proficient speaker of the Dutch language
• • 11. No contra-indications for CVI surgery
• • 12. Active participation in the trial related procedures such as regular testing, the VI fitting period, the baseline testing day and three weeks of intensive VI rehabilitation and testing in the study center (MUMC+) including an exercise regimen
• • 13. Agreed not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the period of VI activation and until at least 1 day after VI deactivation
• • Remark: Patients who qualify to receive a regular CI as part of standard clinical care will have a preferential position to be included in the trial.
• Exclusion Criteria:
• • 1. Signs of central vestibular/cochlear dysfunction or structural vestibular/cochlear nerve pathology (judged by physical examination / MRI)
• • 2. Clear signs of structural nerve pathology or indications of improperly functioning vestibular/cochlear nerves
• • 3. Requirement for electric-acoustic activation of the CI part (e.g. "hybrid" processor) prior to completion of the prolonged VI stimulation period
• • 4. Having received a cochlear implant earlier on the side to implant (e.g. explantation/reimplantation)
• • 5. Having received a cochlear implant from another brand than MED-EL in the other ear (bilateral implantation with different brands is not supported)
• • 6. Unwillingness to stop the use of antihistamines which might suppress VOR responses (e.g. cinnarizine) in the period of 1 month before until after each measurement point.
• • 7. Pre-lingual onset of bilateral profound deafness (\< 4 years of age)
• • 8. Active participation in another prospective clinical trial
• • 9. Pregnancy or having plans to become pregnant at the time of imaging or during the VI trial
• • 10. Orthopedic, ocular, neurologic or other non-vestibular pathologic conditions of sufficient severity to confound vestibular function tests used in the study
• • 11. Current psychological or psychiatric disorders that could significantly interfere with the use or evaluation of VI stimulation
• • 12. Physical or non-physical contraindications for MRI or CT imaging prior to surgery
• • 13. Making chronic use of psychiatric medication which suppresses VOR responses (e.g. SSRI's, benzodiazepines)
• • 14. Significant dental problems which prohibit the stable use of a 'bite bar' (used as calibration reference for the gyroscope functionality of the CVI)
• • 15. Any medical condition, judged by the research team, that is likely to interfere with a study candidate's participation in the study