Subthreshold vestibular stimulation to improve balance and motion perception

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll 48 adults (24 with peripheral vestibular hypofunction—12 bilateral and 12 unilateral—and 24 healthy controls) to complete four lab visits. On Day 1 participants will receive a single block of subthreshold motion to measure immediate and short-term retention effects on balance and self-motion perception. On three additional visits performed in random order, participants will complete repeated balance training, repeated subthreshold vestibular stimulation, and a combined balance training plus subthreshold stimulation condition. Outcome measures include changes in motion perception thresholds and objective balance performance following each condition.

Why it matters

Who can join: the full rules

Inclusion Criteria for Bilateral Vestibular Hypofunction:

1\. 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:

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

Inclusion Criteria for all Participants:

1. Must be able to stand for 5 minutes unassisted
2. No leg or foot amputations
3. No lower limb braces
4. Not currently pregnant by self-report
5. Weight \<= 300 pounds (due to limitations of testing equipment)

Exclusion Criteria for all participants:

1. Severe head trauma or traumatic brain injury
2. History of seizures
3. Alternative neurologic illness or condition known to impact vestibular or balance function (e.g., stroke, neurodegenerative disorders, demyelinating illness)
4. Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder
5. 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,
6. Recent (\<6 months) orthopedic injury that may affect test performance
7. Recent surgery (\< 6 months) that may impact test performance.
8. Other severe health problems (heart disease, pulmonary disease, cancer, etc.) that may affect test performance
9. 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.

Where it's running

• Creighton University
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Andrew R Wagner, PhD
• Email: andrewwagner@creighton.edu
• Phone: 402.280.5188

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.