Vestibular DysfunctionNCT07627087
Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant
A study testing vestibular implant stimulation in people with Vestibular Dysfunction and Bilateral Vestibular Loss, run by Massachusetts Eye and Ear Infirmary at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vestibular Dysfunction, Bilateral Vestibular Loss, Vestibular Implant
- What is being tested?
- vestibular implant stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Universite de Geneve
Geneva, 1211 Geneva 4
Angelica Perez-Fornos, PhD, DAS, +41223728246, angelica.perez@unige.ch
Guinand Nils, MD, +41(79)553 39 82, nils.guinand@hcuge.ch
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- vestibular implant stimulation
- Keywords
- bilateral vestibular loss, vestibular implant, neuropsychologic function, cognitive function, spatial orientation, navigation
- Medical subject headings
- Bilateral Vestibulopathy, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular implant stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| "true" stimulation | Active comparator | tonic + motion-modulated stimulation Receives: Device: vestibular implant stimulation |
| "placebo" stimulation | Sham comparator | tonic-only stimulation Receives: Device: vestibular implant stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial Orientation: Changes in Subjective Postural Vertical
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).
Measured: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Spatial Orientation: Changes in Roll Tilt Perceptual Thresholds
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).
Measured: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Changes in Navigation
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).
Measured: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Changes in Neuropsychologic Function
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).
Measured: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start22 Jan 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Vestibular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Geneva, Switzerland, Maastricht University
- Responsible party
- Principal investigator, Richard Lewis, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627087
- Sponsor's protocol ID
- 2025P000498
- Other IDs
- R01DC021981
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at present
Publications
Chari DA, Ahmad M, King S, Boutabla A, Fattahi C, Panic AS, Karmali F, Lewis RF. Vestibular damage affects the precision and accuracy of navigation in a virtual visual environment. Brain Commun. 2023 Dec 8;5(6):fcad345. doi: 10.1093/braincomms/fcad345. eCollection 2023.
PubMed 38116141Peruch P, Borel L, Magnan J, Lacour M. Direction and distance deficits in path integration after unilateral vestibular loss depend on task complexity. Brain Res Cogn Brain Res. 2005 Dec;25(3):862-72. doi: 10.1016/j.cogbrainres.2005.09.012. Epub 2005 Oct 26.
PubMed 16256321Bisdorff AR, Anastasopoulos D, Bronstein AM, Gresty MA. Subjective postural vertical in peripheral and central vestibular disorders. Acta Otolaryngol Suppl. 1995;520 Pt 1:68-71. doi: 10.3109/00016489509125193.
PubMed 8749084Lewis RF. Vestibular implants studied in animal models: clinical and scientific implications. J Neurophysiol. 2016 Dec 1;116(6):2777-2788. doi: 10.1152/jn.00601.2016. Epub 2016 Oct 19.
PubMed 27760820Guinand N, van de Berg R, Cavuscens S, Stokroos RJ, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez-Fornos A. Vestibular Implants: 8 Years of Experience with Electrical Stimulation of the Vestibular Nerve in 11 Patients with Bilateral Vestibular Loss. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):227-240. doi: 10.1159/000433554. Epub 2015 Sep 15.
PubMed 26367113Guinand N, van de Berg R, Ranieri M, Cavuscens S, DiGiovanna J, Nguyen TA, Micera S, Stokroos R, Kingma H, Guyot JP, Perez Fornos A. Vestibular implants: Hope for improving the quality of life of patients with bilateral vestibular loss. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7192-5. doi: 10.1109/EMBC.2015.7320051.
PubMed 26737951Nguyen TAK, Cavuscens S, Ranieri M, Schwarz K, Guinand N, van de Berg R, van den Boogert T, Lucieer F, van Hoof M, Guyot JP, Kingma H, Micera S, Perez Fornos A. Characterization of Cochlear, Vestibular and Cochlear-Vestibular Electrically Evoked Compound Action Potentials in Patients with a Vestibulo-Cochlear Implant. Front Neurosci. 2017 Nov 21;11:645. doi: 10.3389/fnins.2017.00645. eCollection 2017.
PubMed 29209162King S, Dahlem K, Karmali F, Stankovic KM, Welling DB, Lewis RF. Imbalance and dizziness caused by unilateral vestibular schwannomas correlate with vestibulo-ocular reflex precision and bias. J Neurophysiol. 2022 Feb 1;127(2):596-606. doi: 10.1152/jn.00725.2020. Epub 2022 Jan 26.
PubMed 35080420Grabherr L, Cuffel C, Guyot JP, Mast FW. Mental transformation abilities in patients with unilateral and bilateral vestibular loss. Exp Brain Res. 2011 Mar;209(2):205-14. doi: 10.1007/s00221-011-2535-0. Epub 2011 Feb 2.
PubMed 21287158Chari DA, Madhani A, Sharon JD, Lewis RF. Evidence for cognitive impairment in patients with vestibular disorders. J Neurol. 2022 Nov;269(11):5831-5842. doi: 10.1007/s00415-022-11289-3. Epub 2022 Aug 5.
PubMed 35930032Peruch P, Borel L, Gaunet F, Thinus-Blanc G, Magnan J, Lacour M. Spatial performance of unilateral vestibular defective patients in nonvisual versus visual navigation. J Vestib Res. 1999;9(1):37-47.
PubMed 10334015Smith PF. The vestibular system and cognition. Curr Opin Neurol. 2017 Feb;30(1):84-89. doi: 10.1097/WCO.0000000000000403.
PubMed 27845944Hitier M, Besnard S, Smith PF. Vestibular pathways involved in cognition. Front Integr Neurosci. 2014 Jul 23;8:59. doi: 10.3389/fnint.2014.00059. eCollection 2014.
PubMed 25100954Xie Y, Bigelow RT, Frankenthaler SF, Studenski SA, Moffat SD, Agrawal Y. Vestibular Loss in Older Adults Is Associated with Impaired Spatial Navigation: Data from the Triangle Completion Task. Front Neurol. 2017 Apr 27;8:173. doi: 10.3389/fneur.2017.00173. eCollection 2017.
PubMed 28496432Dobbels B, Mertens G, Gilles A, Moyaert J, van de Berg R, Fransen E, Van de Heyning P, Van Rompaey V. The Virtual Morris Water Task in 64 Patients With Bilateral Vestibulopathy and the Impact of Hearing Status. Front Neurol. 2020 Aug 11;11:710. doi: 10.3389/fneur.2020.00710. eCollection 2020.
PubMed 32849193
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Implant Tested in Patients With Peripheral Vestibular Damage: Effects on Spatial Orientation, Navigation, and Neuropsychologic Function
- ClinicalTrials.gov ID
- NCT07627087
- Acronym / sponsor ID
- 2025P000498
- Keywords
- bilateral vestibular loss, vestibular implant, neuropsychologic function, cognitive function, spatial orientation, navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Geneva, Switzerland, Maastricht University
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "true" stimulation | Active comparator | Device: vestibular implant stimulationtonic + motion-modulated stimulation |
| "placebo" stimulation | Sham comparator | Device: vestibular implant stimulationtonic-only stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vestibular implant stimulationTwo 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. | Device | "placebo" stimulation, "true" stimulation |
Primary outcome
Spatial Orientation: Changes in Subjective Postural Vertical
Time frame: 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).
Spatial Orientation: Changes in Roll Tilt Perceptual Thresholds
Time frame: 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).
Changes in Navigation
Time frame: 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).
Changes in Neuropsychologic Function
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 38116141Chari DA, Ahmad M, King S, Boutabla A, Fattahi C, Panic AS, Karmali F, Lewis RF. Vestibular damage affects the precision and accuracy of navigation in a virtual visual environment. Brain Commun. 2023 Dec 8;5(6):fcad345. doi: 10.1093/braincomms/fcad345. eCollection 2023.
- Background: PubMed 16256321Peruch P, Borel L, Magnan J, Lacour M. Direction and distance deficits in path integration after unilateral vestibular loss depend on task complexity. Brain Res Cogn Brain Res. 2005 Dec;25(3):862-72. doi: 10.1016/j.cogbrainres.2005.09.012. Epub 2005 Oct 26.
- Background: PubMed 8749084Bisdorff AR, Anastasopoulos D, Bronstein AM, Gresty MA. Subjective postural vertical in peripheral and central vestibular disorders. Acta Otolaryngol Suppl. 1995;520 Pt 1:68-71. doi: 10.3109/00016489509125193.
- Background: PubMed 27760820Lewis RF. Vestibular implants studied in animal models: clinical and scientific implications. J Neurophysiol. 2016 Dec 1;116(6):2777-2788. doi: 10.1152/jn.00601.2016. Epub 2016 Oct 19.
- Background: PubMed 26367113Guinand N, van de Berg R, Cavuscens S, Stokroos RJ, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez-Fornos A. Vestibular Implants: 8 Years of Experience with Electrical Stimulation of the Vestibular Nerve in 11 Patients with Bilateral Vestibular Loss. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):227-240. doi: 10.1159/000433554. Epub 2015 Sep 15.
- Background: PubMed 26737951Guinand N, van de Berg R, Ranieri M, Cavuscens S, DiGiovanna J, Nguyen TA, Micera S, Stokroos R, Kingma H, Guyot JP, Perez Fornos A. Vestibular implants: Hope for improving the quality of life of patients with bilateral vestibular loss. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7192-5. doi: 10.1109/EMBC.2015.7320051.
- Background: PubMed 29209162Nguyen TAK, Cavuscens S, Ranieri M, Schwarz K, Guinand N, van de Berg R, van den Boogert T, Lucieer F, van Hoof M, Guyot JP, Kingma H, Micera S, Perez Fornos A. Characterization of Cochlear, Vestibular and Cochlear-Vestibular Electrically Evoked Compound Action Potentials in Patients with a Vestibulo-Cochlear Implant. Front Neurosci. 2017 Nov 21;11:645. doi: 10.3389/fnins.2017.00645. eCollection 2017.
- Background: PubMed 35080420King S, Dahlem K, Karmali F, Stankovic KM, Welling DB, Lewis RF. Imbalance and dizziness caused by unilateral vestibular schwannomas correlate with vestibulo-ocular reflex precision and bias. J Neurophysiol. 2022 Feb 1;127(2):596-606. doi: 10.1152/jn.00725.2020. Epub 2022 Jan 26.
- Background: PubMed 21287158Grabherr L, Cuffel C, Guyot JP, Mast FW. Mental transformation abilities in patients with unilateral and bilateral vestibular loss. Exp Brain Res. 2011 Mar;209(2):205-14. doi: 10.1007/s00221-011-2535-0. Epub 2011 Feb 2.
- Background: PubMed 35930032Chari DA, Madhani A, Sharon JD, Lewis RF. Evidence for cognitive impairment in patients with vestibular disorders. J Neurol. 2022 Nov;269(11):5831-5842. doi: 10.1007/s00415-022-11289-3. Epub 2022 Aug 5.
- Background: PubMed 10334015Peruch P, Borel L, Gaunet F, Thinus-Blanc G, Magnan J, Lacour M. Spatial performance of unilateral vestibular defective patients in nonvisual versus visual navigation. J Vestib Res. 1999;9(1):37-47.
- Background: PubMed 27845944Smith PF. The vestibular system and cognition. Curr Opin Neurol. 2017 Feb;30(1):84-89. doi: 10.1097/WCO.0000000000000403.
- Individual participant dataSharing planned: Undecided. Undecided at present
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Vestibular Dysfunction, Dizziness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular implant stimulation in people with Vestibular Dysfunction and Bilateral Vestibular Loss, run by Massachusetts Eye and Ear Infirmary at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard F Lewis, MD (617-573- 3501, richard_lewis@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial Orientation: Changes in Subjective Postural Vertical (time frame: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07627087, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.