Subthreshold vestibular stimulation to improve balance and motion perception

Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation

This test will see if very-low-level (subthreshold) vestibular stimulation, alone or combined with balance training, helps adults with unilateral or bilateral vestibular hypofunction and healthy adults improve balance and motion perception.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 19 Years to 89 Years
• Sex: All
• Sponsor: Creighton University (Academic / other)
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT06732440 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults who can stand unassisted for five minutes, meet the clinical criteria for unilateral or bilateral vestibular hypofunction (vHIT gain < 0.8 or positive bedside head impulse), and meet the study's safety and weight limits.

Not a fit: People with alternative neurologic conditions that affect balance (such as stroke or neurodegenerative disease), severe head trauma, a history of seizures, major psychiatric illness, significant eye disease, or inability to stand safely are unlikely to be helped or to qualify for participation.

Why it matters

Potential benefit: If successful, this approach could offer a simple, noninvasive way to improve balance and self-motion perception and to enhance the effects of standard balance training.

How similar studies have performed: Laboratory and early human research show the vestibular system can adjust sensitivity after prolonged motion, but applying subthreshold vestibular stimulation as a rehabilitation strategy is relatively novel and not yet widely tested in clinical trials.

Eligibility criteria

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 this trial is running

Omaha, Nebraska

• Creighton University — Omaha, Nebraska, United States (Recruiting)

Study contacts

• Study coordinator: Andrew R Wagner, PhD

Conditions Vestibular Hypofunction; Bilateral Vestibular Hypofunction; Presbyvestibulopathy; Healthy Controls; Vestibular Rehabilitation