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Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant

30 mai 2026 mis à jour par: Richard Lewis, Massachusetts Eye and Ear Infirmary

Vestibular Implant Tested in Patients With Peripheral Vestibular Damage: Effects on Spatial Orientation, Navigation, and Neuropsychologic Function

The vestibular system, located in the inner ear, provides information to the brain information about how head acceleration and orientation relative to gravity. Damage to the vestibular system is usually permanent and can contribute to a lower quality of life. The goal of this research is to to examine how vestibular implants (VI) may improve performance of cognitive tasks in patients with severe vestibular damage. These higher-level cognitive behaviors include (1) orientation relative to gravity, (2) navigation, and (3) neuropsychologic function. VI patients will be tested in these three cognitive domains across study sessions: pre-stimulation (VI implanted but stimulation OFF), following chronic stimulation (12 days, VI-ON), and then again 1 month later with the VI turned off. There will be both "true" stimulation experiments during which the VI will provide motion-modulated stimulation and also "placebo" stimulation (no motion cues, tonic stimulus). The order of these experiments will be randomized and separated by 3 months. Researchers will compare VI data in the three cognitive domains (spatial orientation, navigation, & neuropsychologic function) with control data from non-implanted bilateral vestibular loss (BVL) and unilateral vestibular loss (UVL) patients and normal subjects.

Aperçu de l'étude

Description détaillée

This project will test the capability of a vestibular implant (VI) to improve cognitive dysfunction in patients with severe vestibular damage. At Mass Eye and Ear (MEE), we will test non-implant vestibular patients with differing degrees of vestibular damage. At the University of Geneva (UNIGE), they will recruit and implant patients with severe vestibular and auditory deficits with a combined cochlear and vestibular implant. These are the patients with VIs we intend to test in collaboration with the UNIGE team. Notably, all implant surgeries are done at UNIGE as part of their ongoing vestibular implant research. The team at MEE submitting this CT.gov study is not involved with any aspect of the recruitment, surgery, or post-operative care of the patients receiving implants at UNIGE. We will work with the team at UNIGE to study these patients after they have received the VI on the protocols described below before, during, and after they receive stimulation from the VI. Specifically, we will measure how higher-level behaviors, including spatial orientation, navigation, and neuropsychologic function, are affected by stimulation provided by the vestibular implant, and in parallel will study these behaviors in non-implanted patients with different degrees of vestibular impairment. Our goal is to determine if the cognitive dysfunction experienced by patients with severe vestibular damage can be improved with prosthetic stimulation, findings which would expand the clinical utility of the vestibular implant while concomitantly improving understanding of the role of vestibular information in cognition. Damage to the vestibular periphery is typically permanent and untreatable (aside from physical therapy), and when it is bilateral, can result in severe degradation of vestibular-dependent behaviors. The VI was developed as a vestibular analogue to the widely employed cochlear implant, senses the head's angular velocity in three-dimensions, and provides this information to the brain by stimulating semicircular canal afferents using implanted electrodes. While VI research has progressed from animal models to human patients with vestibular damage, it has focused almost exclusively on eye movements and to a lesser extent balance and gait (although recent human studies also queried subjective measures of dizziness and quality of life). Cognitive processes have been ignored in prior VI studies, even though cognitive symptoms (often referred to as "brain fog") can be prominent and disabling in vestibular-deficient patients. More generally, vestibular contributions to cognition remain controversial and poorly characterized. In this study, we will investigate the effects of VI stimulation on (1) spatial orientation, (2) navigation, and (3) neuropsychologic function by characterizing these behaviors in patients with bilateral vestibular loss (BVL) who have unilateral VIs, with and without chronic vestibular stimulation. To serve as benchmarks for the BVL patients with/without VI stimulation, and to define the effects of vestibular loss on cognitive behavior, we will also study non-implanted BVL and unilateral vestibular loss (UVL) patients and normal subjects. Subjective assessments of cognitive function, dizziness and perceived disability will be also be measured using patient reported outcome measures (PROMs) and we will also assess more general quality-of-life metrics. We predict that the VI will improve spatial orientation, navigation, and visuo-spatial neuropsychologic function in BVL patients and that these measures will display correlations with the PROMs that characterize symptom severity and quality-of-life metrics. In sum, the proposed work will be the first to examine the capability of chronic VI stimulation to improve the cognitive deficits caused by severe vestibular damage, and will also examine the association between the severity of vestibular damage and the degree of cognitive deficits, and the relationship between vestibular-mediated cognitive deficits and the metrics that quantify subjective disability. This work will advance scientific knowledge while promoting the development of the VI as a therapy that has the potential to improve the clinical status and quality-of-life for vestibular-deficient patients.

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Geneva, Suisse, 1211 Geneva 4
        • Recrutement
        • Universite de Geneve
        • Contact:
        • Contact:
        • Chercheur principal:
          • Angelica Perez-Fornos, PhD, DAS

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

  1. Patients receiving vestibular implants at UNIGE:

    Their inclusion criteria are defined as follows:

    • Deaf, scheduled for CI surgery
    • Minimum of five year history of documented absence of bilateral auditory and vestibular function, based on review of their audiograms and vestibular tests.
    • Vestibular testing consistent with BVL
    • No neurologic disease. note: these patients are recruited and implanted by the group at the University of Geneva Hospital (UNIGE) as part of their ongoing research. The study team are not involved in any way with the decision to surgically implant patients with cochlear or vestibular implants, nor are the researchers involved in any way with pre- or post-operative clinical care. The researchers only involvement is to perform the cognitive tests before, during, and after relatively short periods of stimulation using the vestibular implant (VI)
  2. Vestibular patients tested at MEE: vestibular testing consistent with unilateral or bilateral vestibular damage.

Both aspects of the study share the same exclusion criteria:

Exclusion Criteria:

  • No known neurologic or otologic disease other than the vestibular and auditory deficits noted above.
  • Pregnancy. Pregnant women and women up to 4 months postpartum will be excluded because of the known effects and unknown potential effects of pregnancy on sensory function.
  • Body weight >250 lbs (due to motion device safety limits)
  • The chronic use of vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
  • Inability to stand or walk unassisted.
  • Blindness.
  • Unstable medical condition.
  • Orthopedic or musculoskeletal injuries/conditions that affect gait or balance.
  • Ongoing neck or spinal pain/injuries or recent history of neck or spinal surgery
  • Amputation, musculoskeletal deformity, or significant leg-length discrepancy
  • A history of severe head trauma.
  • Any major psychiatric disorder (e.g., psychosis, schizophrenia, panic disorder), not including anxiety or depression.
  • Severe heart or pulmonary conditions
  • Active cancer for which chemo-/radiation therapy is being received.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: "true" stimulation
tonic + motion-modulated stimulation
Two types of stimulation are used, tonic + motion-modulated ("true") & tonic-only ("placebo") stimulation; order is randomized. The VI stimulation period prior to testing is 12 days. For the experiments, the VI is connected to the head-mounted prosthetic circuit and then stimulation is activated. The stimulation unit is the current-balanced biphasic pulse, and the pulse amplitude for each subject is determined through a tuning procedure. Experiments start with an adaptation to tonic baseline stimulation with the head stationary (~30 min). Motion-modulated stimulation employs 3 angular velocity sensors (one aligned with the sensitive axis of each canal), the transduced head velocity signal is high-pass filtered to simulate normal canal dynamics, and filtered head velocity is used to modulate the strength (magnitude, rate) of the electrical stimulation provided by the corresponding implanted electrode. Stimulation strength adjusts for head rotations that change canal afference.
Comparateur factice: "placebo" stimulation
tonic-only stimulation
Two types of stimulation are used, tonic + motion-modulated ("true") & tonic-only ("placebo") stimulation; order is randomized. The VI stimulation period prior to testing is 12 days. For the experiments, the VI is connected to the head-mounted prosthetic circuit and then stimulation is activated. The stimulation unit is the current-balanced biphasic pulse, and the pulse amplitude for each subject is determined through a tuning procedure. Experiments start with an adaptation to tonic baseline stimulation with the head stationary (~30 min). Motion-modulated stimulation employs 3 angular velocity sensors (one aligned with the sensitive axis of each canal), the transduced head velocity signal is high-pass filtered to simulate normal canal dynamics, and filtered head velocity is used to modulate the strength (magnitude, rate) of the electrical stimulation provided by the corresponding implanted electrode. Stimulation strength adjusts for head rotations that change canal afference.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Spatial Orientation: Changes in Subjective Postural Vertical
Délai: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Spatial orientation (subjective postural vertical) results are assessed for their accuracy and precision. Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Spatial Orientation: Changes in Roll Tilt Perceptual Thresholds
Délai: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Spatial orientation (roll tilt perceptual thresholds) results are assessed for their accuracy and precision. Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Changes in Navigation
Délai: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Navigation in a virtual reality visual environment is tested using a 'complete the triangle' task and results are assessed for their accuracy and precision. Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Changes in Neuropsychologic Function
Délai: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Visuospatial and non-visuospatial neuropsychologic function are assessed using a standard battery of neuropsychologic tests. Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
pre-stim, chronic stim (1month + 12 days), and post-stim (1month)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 janvier 2026

Achèvement primaire (Estimé)

31 juillet 2029

Achèvement de l'étude (Estimé)

31 juillet 2029

Dates d'inscription aux études

Première soumission

30 mai 2026

Première soumission répondant aux critères de contrôle qualité

30 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

Undecided at present

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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