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Search / Trial NCT06732440

Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation

Launched by CREIGHTON UNIVERSITY · Dec 10, 2024

Trial Information

Current as of August 21, 2025

Not yet recruiting

Keywords

Bilateral Vestibular Hypofunction Vestibular Rehabilitation

ClinConnect Summary

This clinical trial is studying a new approach to help improve balance and reduce dizziness in people with a condition called bilateral vestibular hypofunction (BVH). BVH affects the inner ear, which is responsible for balance, and it can make everyday activities challenging. Symptoms include feeling off-balance, having a wobbly vision when moving your head, and a higher risk of falling. The trial aims to see if a technique called subthreshold vestibular stimulation—using gentle movements—can enhance the effectiveness of balance training for individuals with BVH.

To participate, you need to be an adult who has experienced symptoms for at least three months, such as unsteadiness while walking or standing. You should also be able to stand without assistance and weigh no more than 300 pounds. People with certain medical conditions, severe injuries, or who are pregnant cannot take part in the study. If you join, you can expect to receive specialized balance training combined with this new stimulation method, which may help improve your balance and overall quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Bilateral yaw aVOR gain of \< 0.8 on video head impulse testing OR bilateral positive bedside head impulse test
  • Symptoms of at least 3-month duration that include (a) Unsteadiness with walking or standing, (b) Either oscillopsia or worsened balance on uneven ground or with vision removed, and (c) No symptoms sitting or lying down.
  • Must be able to stand
  • No leg or foot amputations
  • No lower limb braces
  • Not currently pregnant by self-report
  • Weight \<= 300 pounds
  • Exclusion Criteria:
  • 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 to the lower extremities that may affect test performance
  • Upper extremity injuries requiring current sling immobilization
  • Recent surgery (\< 6 months) that may impact test performance.
  • Any other severe health problem (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 we cannot address every possible potential individual recruit in advance, additional exclusion criteria may be required.

About Creighton University

Creighton University is a distinguished institution dedicated to advancing healthcare through innovative research and clinical trials. As a clinical trial sponsor, Creighton University leverages its robust academic resources and commitment to evidence-based practices to explore new treatment modalities and improve patient outcomes. The university's interdisciplinary approach fosters collaboration among healthcare professionals, researchers, and students, ensuring that clinical trials are conducted with the highest ethical standards and scientific rigor. By prioritizing participant safety and engagement, Creighton University aims to contribute significantly to the body of medical knowledge and enhance the quality of care within the community and beyond.

Locations

Omaha, Nebraska, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported