Vestibular HypofunctionNCT06732440
Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation
A study testing Subthreshold Vestibular Conditioning, Balance Training and Balance Training Plus Subthreshold Conditioning in people with Vestibular Hypofunction and Bilateral Vestibular Hypofunction, run by Creighton University at 1 site in United States.
Trial summary
The nervous system responds to changes in external or internal conditions by altering the behavior of neurons through multiple forms of neural plasticity. A specific form of plasticity, "homeostatic plasticity", stabilizes neural activity by driving the excitability of neurons toward a "set-point" level of activity. Read more about this study
- Who is it for?
- Ages 19 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Hypofunction, Bilateral Vestibular Hypofunction, Presbyvestibulopathy
- What is being tested?
- Subthreshold Vestibular Conditioning, Balance Training and Balance Training Plus Subthreshold Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 31 Dec 2026
- 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 19 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Bilateral lateral canal VOR gain of < 0.8 on video head impulse testing OR bilateral positive bedside head impulse test
- 1. Unilateral yaw aVOR gain of < 0.8 on video head impulse testing OR unilateral positive bedside head impulse test
- Must be able to stand for 5 minutes unassisted
- No leg or foot amputations
- No lower limb braces
- Not currently pregnant by self-report
- Weight <= 300 pounds (due to limitations of testing equipment)
Who cannot join
- Severe head trauma or traumatic brain injury
- History of seizures
- Alternative neurologic illness or condition known to impact vestibular or balance function (e.g., stroke, neurodegenerative disorders, demyelinating illness)
- Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder
- Any of the following eye diseases or conditions: amblyopia (or "lazy eye") or history of amblyopia, diagnosis of age- related macular degeneration, retina dystrophy, glaucoma, cataracts,
- Recent (<6 months) orthopedic injury that may affect test performance
Show all 10Show fewer
- Recent surgery (< 6 months) that may impact test performance.
- Other severe health problems (heart disease, pulmonary disease, cancer, etc.) that may affect test performance
- Due to potentially nauseogenic nature of some motions and to protect fetus and mother, pregnant women will also be excluded from this study
- Since the investigators cannot address every possible potential individual recruit in advance, additional exclusion criteria may be required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Creighton University
Omaha, Nebraska, 68178
Andrew R Wagner, PhD, 402.280.5188 ext. 3702, andrewwagner@creighton.edu
About this study
The nervous system responds to changes in external or internal conditions by altering the behavior of neurons through multiple forms of neural plasticity. A specific form of plasticity, "homeostatic plasticity", stabilizes neural activity by driving the excitability of neurons toward a "set-point" level of activity. Over the last six years, new data have come to light showing that the vestibular system also possess a robust capacity to modulate sensitivity to self-motion cues in response to prolonged periods of motion. Collectively, these studies have demonstrated a capacity to use motion perturbations (i.e., low, or high levels of vestibular stimulation) to dynamically adjust the sensitivity of the vestibular system on both the single neuron and behavioral levels. The ability to use subthreshold motion stimuli to drive plasticity in the vestibular system motivates this study. The investigators aim to determine the impact of subthreshold motion on (a) balance performance and (b) balance training in individuals with peripheral vestibular hypofunction.
Read the detailed description
The investigators aim to test (1) if sub threshold motion improves motion perception, (2) if sub threshold motion improves balance performance, and (3) if sub threshold motion prior to balance training leads to improved balance performance. Twenty-four subjects with peripheral vestibular hypofunction (12 with bilateral and 12 with unilateral hypofunction) and twenty-four healthy control participants will complete the study. Each participant will complete four visits to the laboratory. Day 1 will measure the capacity to modify balance and self-motion perception after a single block of subthreshold motion, including any retention effects after a washout period. Days 2-4 will be performed in random order and will test changes in balance and self-motion perception after (a) repeated balance training, (b) repeated subthreshold motion, and (c) balance training combined with sub threshold motion.
- Conditions
- Vestibular Hypofunction, Bilateral Vestibular Hypofunction, Presbyvestibulopathy, Healthy Controls
- Being tested
- Subthreshold Vestibular Conditioning, Balance Training, Balance Training Plus Subthreshold Conditioning
- Keywords
- Bilateral Vestibular Hypofunction, Vestibular Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthreshold Vestibular ConditioningBehavioural
Subthreshold vestibular conditioning will be performed while seated on a motion platform and blindfolded. The stimulus will consist of a pseudorandom sum-of-sinusoids roll tilt motion (~0.08 to 1 Hz) delivered at a peak velocity equal to 57.4% of the measured baseline roll tilt perceptual threshold (e.g., 0.574°/s for a 1 °/s threshold). The participant will be informed that while the chair may vibrate or move slightly, the motion will not occur in any particular direction.
Balance TrainingBehavioural
Balance training will consist of progressive exposure to continuous one-dimensional roll pseudorandom platform perturbations delivered using a 6DoF motion platform. Participants will stand on a MOOG hexapod motion platform and will be secured using a safety harness tethered to the ceiling and a full enclosure of safety rails. Roll tilt perturbations will be progressed by gradually increasing the displacement/velocity/acceleration of the platform motion.
Balance Training Plus Subthreshold ConditioningOther
Subthreshold vestibular conditioning will be performed while seated on a motion platform and blindfolded prior to each bout of balance training. Subthreshold conditioning will consist of a pseudorandom sum-of-sinusoids roll tilt motion (~0.08 to 1 Hz) delivered at a peak velocity equal to 57.4% of the measured baseline roll tilt perceptual threshold (e.g., 0.574°/s for a 1 °/s threshold). The participant will be informed that while the chair may vibrate or move slightly, the motion will not occur in any particular direction. Balance training will consist of progressive exposure to continuous two-dimensional (2D) pseudorandom platform perturbations delivered using a 6DoF motion platform. 2D perturbations (roll and pitch tilt) will be progressed by gradually increasing the displacement/velocity/acceleration of the motion stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Balance training performed with and without added subthreshold conditioning. | Experimental | Each participant in this single group design will complete the same three conditions of the experiment in a randomized order. Receives: Behavioral: Subthreshold Vestibular Conditioning; Behavioral: Balance Training; Other: Balance Training Plus Subthreshold Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perturbed Stance Postural Control
The RMSD of mediolateral (ML) and anteroposterior (AP) postural sway will be measured in response to pseudorandom two-dimensional mediolateral and anteroposterior tilts of the support surface delivered using a 6DoF motion platform. Participants will stand with eyes closed and feet at a standardized distance on top of the motion platform. The platform will tilt simultaneously in both the roll and pitch planes, with each plane of tilt having independent frequency spectra (~0.08 to 1 Hz). The perturbation test will last approximately 2 minutes.
Measured: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).
Vestibular Perceptual Thresholds - 0.5Hz Roll Tilt
Vestibular perceptual thresholds will be measured using a forced-choice direction recognition task using methods that the investigators have used extensively. Subjects will be tilted in the coronal plane (i.e., roll tilt) in one of two directions (e.g., towards the left or right) in complete darkness while seated on a 6DoF platform. To mask potential auditory directionality cues, auditory "noise" - uncorrelated with motion (amplitude, direction, or type) - will be applied at approximately 60 dB SPL. Motion stimuli will consist of single cycles of sinusoidal acceleration. After each motion, the participant will be asked to judge the direction of the tilt stimulus, with the threshold being defined as the smallest velocity of tilt that can be accurately perceived.
Measured: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start9 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vestibular HypofunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will complete all four days of the study.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732440
- Sponsor's protocol ID
- 2004550
- Other IDs
- 4R00DC020759-02
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wagner AR, Kobel MJ, Tajino J, Merfeld DM. Improving self-motion perception and balance through roll tilt perceptual training. J Neurophysiol. 2022 Sep 1;128(3):619-633. doi: 10.1152/jn.00092.2022. Epub 2022 Jul 27.
PubMed 35894439Dietrich H, Straka H. Prolonged vestibular stimulation induces homeostatic plasticity of the vestibulo-ocular reflex in larval Xenopus laevis. Eur J Neurosci. 2016 Jul;44(1):1787-96. doi: 10.1111/ejn.13269. Epub 2016 Jun 1.
PubMed 27152983Kobel MJ, Wagner AR, Merfeld DM, Mattingly JK. Vestibular Thresholds: A Review of Advances and Challenges in Clinical Applications. Front Neurol. 2021 Feb 19;12:643634. doi: 10.3389/fneur.2021.643634. eCollection 2021.
PubMed 33679594
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation
- ClinicalTrials.gov ID
- NCT06732440
- Acronym / sponsor ID
- 2004550
- Conditions
- Vestibular Hypofunction, Bilateral Vestibular Hypofunction, Presbyvestibulopathy, Healthy Controls
- Keywords
- Bilateral Vestibular Hypofunction, Vestibular Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (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 nervous system responds to changes in external or internal conditions by altering the behavior of neurons through multiple forms of neural plasticity. A specific form of plasticity, "homeostatic plasticity", stabilizes neural activity by driving the excitability of neurons toward a "set-point" level of activity. Over the last six years, new data have come to light showing that the vestibular system also possess a robust capacity to modulate sensitivity to self-motion cues in response to prolonged periods of motion. Collectively, these studies have demonstrated a capacity to use motion perturbations (i.e., low, or high levels of vestibular stimulation) to dynamically adjust the sensitivity of the vestibular system on both the single neuron and behavioral levels. The ability to use subthreshold motion stimuli to drive plasticity in the vestibular system motivates this study. The investigators aim to determine the impact of subthreshold motion on (a) balance performance and (b) balance training in individuals with peripheral vestibular hypofunction.
Detailed description
The investigators aim to test (1) if sub threshold motion improves motion perception, (2) if sub threshold motion improves balance performance, and (3) if sub threshold motion prior to balance training leads to improved balance performance. Twenty-four subjects with peripheral vestibular hypofunction (12 with bilateral and 12 with unilateral hypofunction) and twenty-four healthy control participants will complete the study. Each participant will complete four visits to the laboratory. Day 1 will measure the capacity to modify balance and self-motion perception after a single block of subthreshold motion, including any retention effects after a washout period. Days 2-4 will be performed in random order and will test changes in balance and self-motion perception after (a) repeated balance training, (b) repeated subthreshold motion, and (c) balance training combined with sub threshold motion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will complete all four days of the study.
| Arm | Type | Receives |
|---|---|---|
| Balance training performed with and without added subthreshold conditioning. | Experimental | Behavioral: Subthreshold Vestibular Conditioning, Behavioral: Balance Training, Other: Balance Training Plus Subthreshold ConditioningEach participant in this single group design will complete the same three conditions of the experiment in a randomized order. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Bilateral lateral canal VOR gain of < 0.8 on video head impulse testing OR bilateral positive bedside head impulse test
- 1. Unilateral yaw aVOR gain of < 0.8 on video head impulse testing OR unilateral positive bedside head impulse test
- Must be able to stand for 5 minutes unassisted
- No leg or foot amputations
- No lower limb braces
Key exclusion criteria (10 listed)
- Severe head trauma or traumatic brain injury
- History of seizures
- Alternative neurologic illness or condition known to impact vestibular or balance function (e.g., stroke, neurodegenerative disorders, demyelinating illness)
- Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder
- Any of the following eye diseases or conditions: amblyopia (or "lazy eye") or history of amblyopia, diagnosis of age- related macular degeneration, retina dystrophy, glaucoma, cataracts,
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 |
|---|---|---|
| Subthreshold Vestibular ConditioningSubthreshold vestibular conditioning will be performed while seated on a motion platform and blindfolded. The stimulus will consist of a pseudorandom sum-of-sinusoids roll tilt motion (~0.08 to 1 Hz) delivered at a peak velocity equal to 57.4% of the measured baseline roll tilt perceptual threshold (e.g., 0.574°/s for a 1 °/s threshold). The participant will be informed that while the chair may vibrate or move slightly, the motion will not occur in any particular direction. | Behavioural | Balance training performed with and without added subthreshold conditioning. |
| Balance TrainingBalance training will consist of progressive exposure to continuous one-dimensional roll pseudorandom platform perturbations delivered using a 6DoF motion platform. Participants will stand on a MOOG hexapod motion platform and will be secured using a safety harness tethered to the ceiling and a full enclosure of safety rails. Roll tilt perturbations will be progressed by gradually increasing the displacement/velocity/acceleration of the platform motion. | Behavioural | Balance training performed with and without added subthreshold conditioning. |
| Balance Training Plus Subthreshold ConditioningSubthreshold vestibular conditioning will be performed while seated on a motion platform and blindfolded prior to each bout of balance training. Subthreshold conditioning will consist of a pseudorandom sum-of-sinusoids roll tilt motion (~0.08 to 1 Hz) delivered at a peak velocity equal to 57.4% of the measured baseline roll tilt perceptual threshold (e.g., 0.574°/s for a 1 °/s threshold). The participant will be informed that while the chair may vibrate or move slightly, the motion will not occur in any particular direction. Balance training will consist of progressive exposure to continuous two-dimensional (2D) pseudorandom platform perturbations delivered using a 6DoF motion platform. 2D perturbations (roll and pitch tilt) will be progressed by gradually increasing the displacement/velocity/acceleration of the motion stimulus. | Other | Balance training performed with and without added subthreshold conditioning. |
Primary outcome
Perturbed Stance Postural Control
Time frame: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).
The RMSD of mediolateral (ML) and anteroposterior (AP) postural sway will be measured in response to pseudorandom two-dimensional mediolateral and anteroposterior tilts of the support surface delivered using a 6DoF motion platform. Participants will stand with eyes closed and feet at a standardized distance on top of the motion platform. The platform will tilt simultaneously in both the roll and pitch planes, with each plane of tilt having independent frequency spectra (~0.08 to 1 Hz). The perturbation test will last approximately 2 minutes.
Vestibular Perceptual Thresholds - 0.5Hz Roll Tilt
Time frame: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).
Vestibular perceptual thresholds will be measured using a forced-choice direction recognition task using methods that the investigators have used extensively. Subjects will be tilted in the coronal plane (i.e., roll tilt) in one of two directions (e.g., towards the left or right) in complete darkness while seated on a 6DoF platform. To mask potential auditory directionality cues, auditory "noise" - uncorrelated with motion (amplitude, direction, or type) - will be applied at approximately 60 dB SPL. Motion stimuli will consist of single cycles of sinusoidal acceleration. After each motion, the participant will be asked to judge the direction of the tilt stimulus, with the threshold being defined as the smallest velocity of tilt that can be accurately perceived.
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 17 Mar 2026.
- Background: PubMed 35894439Wagner AR, Kobel MJ, Tajino J, Merfeld DM. Improving self-motion perception and balance through roll tilt perceptual training. J Neurophysiol. 2022 Sep 1;128(3):619-633. doi: 10.1152/jn.00092.2022. Epub 2022 Jul 27.
- Background: PubMed 27152983Dietrich H, Straka H. Prolonged vestibular stimulation induces homeostatic plasticity of the vestibulo-ocular reflex in larval Xenopus laevis. Eur J Neurosci. 2016 Jul;44(1):1787-96. doi: 10.1111/ejn.13269. Epub 2016 Jun 1.
- Background: PubMed 33679594Kobel MJ, Wagner AR, Merfeld DM, Mattingly JK. Vestibular Thresholds: A Review of Advances and Challenges in Clinical Applications. Front Neurol. 2021 Feb 19;12:643634. doi: 10.3389/fneur.2021.643634. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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 Subthreshold Vestibular Conditioning, Balance Training and Balance Training Plus Subthreshold Conditioning in people with Vestibular Hypofunction and Bilateral Vestibular Hypofunction, run by Creighton University at 1 site in United States.
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 7 inclusion and 10 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 17 Mar 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 United States. 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. 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 Andrew R Wagner, PhD (402.280.5188 ext. 3702, andrewwagner@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perturbed Stance Postural Control (time frame: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).). The study lists 2 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 NCT06732440, which also lists 3 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 17 Mar 2026.