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NCT Number: NCT06732440

Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation

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.

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Key information

Age range

19 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68178, United States

Location status: Recruiting

Location contact

Andrew R Wagner, PhD

CONTACT

[email protected]

402.280.5188 ext. 3702

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Bilateral Vestibular Hypofunction:

  • Bilateral lateral canal VOR gain of < 0.8 on video head impulse testing OR bilateral positive bedside head impulse test

Inclusion criteria

for Unilateral Vestibular Hypofunction:

  • Unilateral yaw aVOR gain of < 0.8 on video head impulse testing OR unilateral positive bedside head impulse test

Inclusion criteria

for all Participants:

  • 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)

Exclusion criteria

for all participants:

  • 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
  • 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.

Treatment and study plan

Subthreshold Vestibular Conditioning

Behavioral

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 training

Behavioral

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 Conditioning

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Symptom Severity

    Time frame: Subjective outcome measures will be captured only on the first visit, prior to completing any intervention conditions.

    Each participant will complete standardized questionnaires to assess symptom severity including: (a) dizziness (Dizziness Handicap Inventory), a measure of perceived handicap due to dizziness, with higher scores indicating more severe disability related handicap; (b) balance confidence (Activities Balance Confidence Scale), a measure of balance confidence, with higher scores indicating a higher degree of confidence in balance; and (c) impact of vestibular symptoms on daily life (Vestibular Activities of Daily Living Scale), a measure describing the impact of vestibular symptoms on activities of daily living, with higher scores indicating a greater impact of vestibular symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew R Wagner, PhD

CONTACT

[email protected]

402.280.5188 ext. 3702

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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