VOR Precision Training for Vestibular Disorders

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Benzodiazepine, Antihistamine, Anticholinergic

Disqualifiers: Otologic, Neurologic, others

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

Compensation: Varies

Number of Visits: 3

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking vestibular suppressant medications like benzodiazepines, antihistamines, or anticholinergics, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment VOR precision training for vestibular disorders?

Research shows that incremental vestibulo-ocular reflex (VOR) adaptation training can improve balance and reduce symptoms in people with vestibular disorders. Studies have demonstrated improvements in VOR gain, which helps stabilize vision during head movements, and enhancements in posture and gait in patients with chronic vestibular issues. ^{1 2 3 4 5}

Is VOR precision training safe for humans?

VOR precision training, as part of vestibular rehabilitation, has been used safely for over 70 years to help people with balance and dizziness issues. Studies show it can improve symptoms without significant safety concerns, even in people with severe vestibular problems. ^{2 3 5 6 7}

How does VOR precision training differ from other treatments for vestibular disorders?

VOR precision training is unique because it focuses on improving the vestibulo-ocular reflex (VOR) through specific exercises that involve head rotations and visual targets, which can enhance balance and gaze stability. This method is distinct from traditional vestibular rehabilitation as it uses incremental adaptation techniques and can be tailored to individual needs, potentially offering more effective results for those with severe vestibular dysfunction. ^{2 3 4 5 8}

What is the purpose of this trial?

This trial measures how accurately people can balance and move their eyes in response to motion, focusing on both healthy individuals and those with balance system damage. The goal is to understand the role of noise in these systems and see if training can help improve accuracy.

Eligibility Criteria

This trial is for people with certain inner ear conditions like Vestibular Schwannoma, requiring surgery, or healthy individuals with normal vestibular function and hearing. Participants should not have other ear or neurological diseases (except migraines) and must not be taking medication that affects the vestibular system.

Inclusion Criteria

For healthy participants: normal results in a standard test for balance and dizziness.

You need to have a hearing test done for each ear if you have a vestibular schwannoma.

I have undergone tests to check my balance before surgery for a brain tumor.

Exclusion Criteria

I have a brain tumor affecting my hearing but no other ear or neurological conditions.

I have no history of ear or brain diseases.

I am not taking any medication for dizziness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Assessment of vestibular precision in patients with vestibular schwannoma before surgery

Varies

1 visit (in-person)

Sub-acute Post-operative Assessment

Assessment of vestibular precision 6 weeks after vestibular nerve surgery

6 weeks

1 visit (in-person)

Chronic Post-operative Assessment

Assessment of vestibular precision 6 months after vestibular nerve surgery

6 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VOR precision training

Trial Overview The study focuses on 'VOR precision training' to understand how noise impacts the balance system in both healthy subjects and those with vestibular damage. It aims to see if patients can learn to better recognize signals amidst this noise, potentially improving balance.

Participant Groups

Group I: Peripheral Vestibular Dysfunction Experimental Treatment 1 Intervention

Patients with unilateral vestibular damage due to monophasic illness such as vestibular neuritis or vestibular schwannoma (VS). For VS patients, the investigators will test them in three states: pre-op, sub-acute post-op (6 weeks), and chronic post-op (6 months).

Group II: Normal Controls Experimental Treatment 1 Intervention

normal control participants - no history of neurologic or inner ear disease

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Findings from Research

The incremental VOR adaptation (IVA) training method significantly improved the vestibulo-ocular reflex (VOR) gain in a 51-year-old male with bilateral vestibular hypofunction, showing improvements of 179% to 600% over 645 days of use.

In addition to enhancing VOR gain, the IVA method also led to improvements in standing posture and gait, indicating its potential effectiveness in rehabilitating individuals with severe vestibular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VOR adaptation training and retention in a patient with profound bilateral vestibular hypofunction. Gimmon, Y., Migliaccio, AA., Kim, KJ., et al.[2020]

Vestibular rehabilitation is an effective exercise-based program that has been shown to improve various symptoms related to vestibular disorders, including imbalance, dizziness, and anxiety, through a process called central compensation.

Recent advancements in techniques such as balance training, gaze stability training, and the use of virtual reality have enhanced the efficacy of vestibular rehabilitation, making it beneficial even for patients with chronic vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Vestibular Rehabilitation. Sulway, S., Whitney, SL.[2019]

The INVENT VPT trial aims to evaluate the effectiveness of a new non-invasive vestibular adaptation training device in improving the vestibulo-ocular reflex in military service members with mild traumatic brain injury and civilians with vestibular hypofunction, addressing a significant gap in evidence-based vestibular rehabilitation practices.

This multi-center randomized controlled crossover trial will compare traditional vestibular rehabilitation methods with the new device, potentially leading to optimized treatment strategies and better outcomes for patients suffering from multi-sensory impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial. Ervin, AM., Schubert, MC., Migliaccio, AA., et al.[2022]

Vestibular rehabilitation therapy (VRT) is an effective exercise-based treatment that helps improve balance, reduce vertigo, and enhance daily activities for individuals with vestibular disorders, regardless of age or the cause of their symptoms.

Key exercises in VRT focus on head-eye movements and balance tasks, and even short, frequent sessions can significantly aid in vestibular recovery by promoting adaptation and substitution mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. Han, BI., Song, HS., Kim, JS.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of Incremental Vestibulo-ocular Reflex Adaptation Training Versus x1 Training in Patients With Chronic Peripheral Vestibular Hypofunction: A Two-Year Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Once-Daily Incremental Vestibular-Ocular Reflex Adaptation Training in Patients With Chronic Peripheral Vestibular Hypofunction: A 1-Week Randomized Controlled Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

VOR adaptation training and retention in a patient with profound bilateral vestibular hypofunction. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Human Vestibulo-Ocular Reflex Adaptation Reduces when Training Demand Variability Increases. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Vestibular Rehabilitation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

New advances regarding adaptation of the vestibulo-ocular reflex. [2020]