Vestibular Stimulation for Vestibular Hypofunction

Overseen By Andrew R Wagner, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Creighton University

Disqualifiers: Severe head trauma, Seizures, Neurologic illness, Psychiatric disorder, Eye diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method to assist individuals with bilateral vestibular hypofunction (BVH), a condition causing dizziness, unsteadiness, and balance issues. The trial will test whether subthreshold vestibular stimulation—a gentle motion used to enhance the vestibular system's response—can improve balance when combined with balance training. Participants will be divided into three groups: one receiving both stimulation and balance training, one receiving only balance training, and one receiving only stimulation. The trial seeks individuals who have experienced unsteadiness while standing or walking for at least three months but do not have symptoms while sitting or lying down. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for BVH.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this vestibular stimulation technique is safe for improving vestibular function?

Research shows that a gentle type of vestibular stimulation might safely assist those with balance issues due to bilateral vestibular hypofunction (BVH). Studies have found that low levels of motion can help adjust the body's balance system, improving balance and movement perception. These studies have not identified any major side effects, indicating that this method is well-tolerated.

The treatment involves gentle tilts that do not fully activate the balance system, helping to prevent common side effects like discomfort or dizziness associated with stronger stimulation.

Although specific phase data for this treatment is unavailable, the absence of negative effects in similar studies suggests it is safe for participants. This type of stimulation has shown promise in improving balance without significant risk. For those considering joining a trial, this information can reassure about the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vestibular stimulation for vestibular hypofunction because it offers a novel approach to improve balance and dizziness symptoms without relying solely on medications or physical therapy. Unlike standard treatments that focus on symptom management, this method involves subthreshold vestibular conditioning, which uses gentle tilts to retrain the brain's balance systems. This could lead to more effective and longer-lasting improvements in balance and stability. Additionally, the treatment's non-invasive nature and potential to enhance natural vestibular function make it an attractive alternative for patients seeking new solutions.

What evidence suggests that subthreshold vestibular conditioning is effective for improving vestibular function in bilateral vestibular hypofunction?

Research has shown that a gentle type of vestibular stimulation can improve balance and reduce falls in individuals with bilateral vestibular hypofunction (BVH), a condition affecting both inner ears. In this trial, participants in the "Balance Plus Motion" arm will receive 20 minutes of passive, subthreshold tilts before balance training, based on methods proven to enhance balance in previous studies. One study found that similar stimulation helped healthy individuals better sense motion. This approach appears to fine-tune the body's balance system, aiding in maintaining an upright position and spatial awareness. These findings suggest that this gentle stimulation could benefit people with BVH by enhancing their balance and reducing their risk of falling. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with Bilateral Vestibular Hypofunction (BVH), including those whose condition may be related to aging, known as Presbyvestibulopathy. Participants should have symptoms like unsteady vision when moving their head, balance issues, and dizziness.

Inclusion Criteria

I can stand up on my own.

No lower limb braces

Not currently pregnant by self-report

Exclusion Criteria

Major psychiatric disorder (e.g., panic disorder, psychosis, etc.)

I have a history of seizures.

I have a history of eye conditions such as lazy eye, macular degeneration, retina dystrophy, glaucoma, or cataracts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Balance performance and secondary outcome measures are assessed prior to training

1 day

1 visit (in-person)

Treatment

Participants undergo balance training with or without subthreshold vestibular stimulation

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for improvements in balance and vestibular function

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Subthreshold Vestibular Conditioning

Trial Overview The study tests whether a new method called subthreshold vestibular stimulation can improve balance and reduce falls in people with BVH. It involves exposing participants to low-level motion cues before balance training to see if it enhances postural control.

How Is the Trial Designed?

Group I: Balance training performed with and without added subthreshold conditioning. Experimental Treatment 3 Interventions

Each participant in this single group design will complete the same three conditions of the experiment in a randomized order.

Who Is Running the Clinical Trial?

Creighton University

Lead Sponsor

Trials

128

Recruited

25,800+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

A randomized controlled trial with 42 patients showed that a 4-week customized exercise program significantly improved symptoms, disability, balance, and postural stability in individuals with chronic unilateral vestibular dysfunction.

In contrast, the control group that did not receive any treatment showed no significant improvements, highlighting the efficacy of vestibular rehabilitation exercises in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. Giray, M., Kirazli, Y., Karapolat, H., et al.[2022]

In a study involving 81 patients with chronic unilateral vestibular hypofunction, a combined exercise protocol (adaptation and habituation exercises) led to significantly better improvements in balance and self-perceived disability compared to single-exercise protocols after 8 weeks.

The combined exercise group showed faster improvements in functional gait and dynamic postural stability, indicating that a multi-faceted approach to vestibular rehabilitation may be more effective than focusing on just one type of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Vestibular Rehabilitation Modalities in Unilateral Vestibular Hypofunction: A Prospective Study. Lilios, A., Chimona, T., Papadakis, C., et al.[2023]

In a study of 25 long-term users of electrical vestibular nerve stimulation (VeNS) over an average of 22 months, no adverse events or significant side effects were reported, indicating a strong safety profile for this treatment.

Formal audiometry tests showed no significant changes in hearing function among 18 users, suggesting that long-term VeNS does not negatively impact hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical vestibular nerve stimulation (VeNS): a follow-up safety assessment of long-term usage. McCulloch, E., Kumar Goothy, SS., McKeown, J.[2022]

A study of 70 patients over 50 years old showed that vestibular rehabilitation therapy significantly improved balance, as measured by the Berg balance test, with scores increasing from 36.8 to 46.4 after therapy.

The therapy effectively reduces fall risk in at-risk elderly patients, demonstrating its importance as a preventive measure, with improvements observed immediately at the end of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of vestibular rehabilitation therapy in reducing falls. Macias, JD., Massingale, S., Gerkin, RD.[2022]

Vestibular physical therapy significantly improved balance and functional outcomes in 48 patients with central vestibular dysfunction, as shown by various assessment measures after an average of 5 therapy visits over 5 months.

Patients with severe disability at baseline experienced greater improvements, although those with cerebellar dysfunction showed the least progress, indicating that the type of vestibular dysfunction may influence therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for central vestibular dysfunction. Brown, KE., Whitney, SL., Marchetti, GF., et al.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06732440

Subthreshold Vestibular Stimulation as a Strategy for ... The primary outcome will be the amount of postural sway, defined as the root mean square displacement (RMSD) of the CoP, measured while standing on a sway ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11274252/

Exploring the Potentials of Wearable Technologies in ... This resulted in improved balance control in healthy subjects and patients with VH.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1542496/full

Differential modification of perceptual thresholds by ... Yet, four out of the five participants with chronic unilateral vestibular hypofunction displayed an improvement in perceptual thresholds (Range ...

4. withpower.com withpower.com/trial/vestibular-stimulation-for-vestibular-hypofunction-78477

Vestibular Stimulation for Vestibular Hypofunction Trial Overview The study tests whether a new method called subthreshold vestibular stimulation can improve balance and reduce falls in people with BVH. It ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0306452222006182

Enhancement of Vestibular Motion Discrimination by Small ... Noisy galvanic vestibular stimulation has been shown to improve vestibular perception in healthy subjects. Here, we sought to obtain similar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7933227/

Vestibular Thresholds: A Review of Advances and Challenges ... This review provides an overview of vestibular perceptual thresholds and the current literature assessing use in clinical populations as a potential diagnostic ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK572153/

Vestibular Rehabilitation - StatPearls - NCBI Bookshelf - NIH Vestibular rehabilitation exercises fall into two main categories: Exercises for canalith repositioning for BPPV, and. Exercises for vestibular hypofunction.[10].

8. researchgate.net researchgate.net/figure/Main-characteristics-of-the-four-sub-groups-of-patients-with-UVH_tbl1_358783004

characteristics of the four sub-groups of patients with UVH. A cohort of 5 individuals (1 female) with chronic unilateral vestibular hypofunction participated in the T0.57x subthreshold conditioning stimulus. Results Yaw ...