Motion Perception Study for Vestibular Disorders

Overseen By Cesar Arduino

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Institutionalized, Nervous system diseases, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how aging and diseases affect motion perception. Researchers will examine sensitivity to movement using a treatment called heading direction adaptation (also known as Heading Perception Adaptation or Directional Adaptation Therapy). The study includes two groups: healthy individuals and those with vestibular disorders, which are balance-related conditions. It suits people with vestibular loss who are otherwise in good health. Participants will help scientists learn more about how balance and motion perception change with age or certain health issues. As an unphased trial, this study allows participants to contribute to foundational research that could lead to new insights and treatments for balance and motion perception issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for measuring motion perception?

Research has shown that vestibular rehabilitation, which includes exercises to help the brain adjust to head movements, is generally safe and well-tolerated. Studies have found that this therapy can reduce dizziness and improve balance in people with vestibular disorders. Although some evidence is limited, the treatment effectively manages symptoms. No significant reports of severe side effects have emerged, suggesting it is a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Motion Perception Study for Vestibular Disorders because it explores heading direction adaptation, a unique approach that aims to enhance how patients perceive motion. Unlike traditional treatments for vestibular disorders, which often involve medications or physical therapy to manage symptoms, this technique focuses on retraining the brain's perception of movement. By specifically targeting the brain's ability to adapt to changes in motion direction, it offers a novel way to potentially improve balance and reduce dizziness in patients. This innovative method could lead to new, non-invasive strategies that directly address the underlying causes of vestibular disorders rather than just alleviating symptoms.

What evidence suggests that heading direction adaptation might be an effective treatment for vestibular disorders?

This trial will compare the effects of heading direction adaptation on healthy subjects and patients with vestibular disorders. Research has shown that adjusting to a certain direction of movement can alter motion perception. One study found that after adapting to a specific movement direction, individuals often perceive movement in that direction even when stationary. This treatment might help reset motion perception, benefiting those with balance problems due to inner ear issues. Strong evidence indicates that vestibular rehabilitation can improve dizziness and balance. The exercises aim to create lasting changes in how the brain responds to movement, potentially enhancing balance and stability. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This study is for people in good health who have lost some or all of their vestibular function, which affects balance, on one or both sides. It aims to understand how aging and diseases impact the way we perceive motion.

Inclusion Criteria

I have hearing loss in one or both ears.

You are in overall good health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo visual and vestibular motion perception tests to measure sensitivity and adaptation

1 week

Multiple sessions for testing and adaptation

Follow-up

Participants are monitored for changes in heading perception and dizziness symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heading direction adaptation

Trial Overview The trial is testing 'Heading direction adaptation' to see how it influences visual and balance-related motion perception. Participants will undergo tests that measure their sensitivity to movement.

How Is the Trial Designed?

Group I: Healthy subjects Active Control 1 Intervention

Group II: Vestibular Disease patients Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Environmental challenges can negatively impact the vestibular system, leading to symptoms like vertigo, imbalance, and autonomic responses, especially in individuals with a disordered vestibular system.

The main treatment approach for conditions like visual vertigo and motion sickness involves progressive desensitization combined with cognitive reassurance and techniques to manage anxiety and autonomic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vertigo and dizziness from environmental motion: visual vertigo, motion sickness, and drivers' disorientation. Bronstein, AM., Golding, JF., Gresty, MA.[2022]

A pilot study involving 30 participants (15 healthy subjects and 15 patients with unilateral vestibular dysfunction) showed that a smartphone-based head-mounted display for vestibular rehabilitation was highly usable, scoring over 80 on the usability scale.

The system induced minimal simulator sickness in healthy subjects after 20-30 minutes of training, while patients experienced more symptoms, suggesting the system is safe and effective for home-based rehabilitation, especially for those with vestibular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-based gaming system for vestibular rehabilitation: A usability study. Nehrujee, A., Vasanthan, L., Lepcha, A., et al.[2020]

Vestibular perceptual thresholds, which measure how well the vestibular system detects head movements, vary with frequency and generally decrease as frequency increases for most types of head movements, except for roll rotations.

Age and clinical status significantly affect these thresholds, with older individuals and patients showing higher thresholds compared to healthy controls, highlighting the importance of these measures for clinical assessments and athletic performance evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human vestibular perceptual thresholds - A systematic review of passive motion perception. Fitze, DC., Mast, FW., Ertl, M.[2023]

Participants adapted to perceive a moving visual stimulus as stationary only when the direction of the stimulus matched the direction of head movement during adaptation, highlighting the importance of context in visual perception.

The study demonstrates that the brain can create dual adaptations based on the frequency of head motion, indicating a complex interaction between visual and vestibular systems in processing movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual adaptation of apparent concomitant motion contingent on head rotation frequency. Post, RB., Welch, RB.[2019]

The study found that healthy participants consistently overestimated the amplitude of passive yaw rotations, regardless of whether they received only vestibular information or combined auditory and vestibular cues, indicating a strong bias in self-motion perception.

The results suggest that auditory cues, whether passively or actively produced, do not significantly improve the accuracy of estimating rotational displacements, but this overestimation bias may help in navigating substantial directional changes in everyday situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much I moved: Robust biases in self-rotation perception. Zanchi, S., Cuturi, LF., Sandini, G., et al.[2022]

A study found that taking 25 mg of promethazine, a common anti-motion sickness drug, significantly increased roll tilt vestibular perceptual thresholds by 31%, indicating a decrease in precision in detecting this type of motion.

No significant changes were observed in yaw rotation and y-translation thresholds, suggesting that while promethazine affects certain vestibular perceptions, it may not impact all types of motion perception equally, which could have practical implications for activities like driving or piloting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Oral Promethazine on Human Whole-Body Motion Perceptual Thresholds. Diaz-Artiles, A., Priesol, AJ., Clark, TK., et al.[2022]

The study involved 70 participants (35 with motion sickness and 35 without) aged 18-40, and it found that both groups showed significant differences in their ability to correctly respond to optokinetic and rotational stimuli during the fHIT test.

The results suggest that fHIT can be an effective objective test for diagnosing motion sickness, as individuals with motion sickness were notably affected by these stimuli compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of effects of optokinetic and rotational stimuli with functional head impulse test (fHIT) in individuals with motion sickness. Karababa, E., Satar, B., Genç, H.[2023]

Training that combines visual and vestibular feedback can significantly improve visual-only self-motion heading perception in older adults, with 27% of participants who initially struggled able to achieve similar performance levels to younger adults after training.

While older adults showed optimal integration of sensory information both before and after training, younger adults only reached this level of integration after the training, suggesting that older adults may benefit more from targeted interventions to enhance their perceptual abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisensory visual-vestibular training improves visual heading estimation in younger and older adults. Gabriel, GA., Harris, LR., Henriques, DYP., et al.[2022]

Patients with bilateral vestibular deficits rely more on visual and nonvestibular cues for spatial orientation compared to healthy individuals, indicating a compensatory mechanism in sensory integration.

The study utilized a novel approach combining psychophysics and Bayesian inference to quantify sensory noise and reweighting strategies, which could enhance diagnostics and rehabilitation strategies for vestibular patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychophysical Evaluation of Sensory Reweighting in Bilateral Vestibulopathy. Medendorp, WP., Alberts, BBGT., Verhagen, WIM., et al.[2020]

Astronauts and vestibular patients experience similar challenges in orientation due to changes in how they process acceleration stimuli, suggesting that research methods for one group could benefit the other.

Two promising ground-based strategies were introduced: one for assessing vestibular adaptation-induced imbalance through a temporary disruption in healthy subjects, and another involving a tactile feedback device aimed at improving balance recovery for those with vestibular issues, both of which need further evaluation in clinical and astronaut settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Neurovestibular Challenges of Astronauts and Balance Patients: Some Past Countermeasures and Two Alternative Approaches to Elicitation, Assessment and Mitigation. Lawson, BD., Rupert, AH., McGrath, BJ.[2020]

Individuals with vestibular disorders experienced significantly greater discomfort and symptoms during coordinated head and eye movements in moving visual environments, with 55-60% of trials resulting in symptoms compared to less than 20% in healthy controls.

The severity of symptoms in those with vestibular dysfunction increased over multiple visits and was correlated with self-reported dizziness handicap, indicating that the challenges of optic flow environments can exacerbate their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms elicited in persons with vestibular dysfunction while performing gaze movements in optic flow environments. Whitney, SL., Sparto, PJ., Cook, JR., et al.[2021]

A study involving 19 subjects (9 in the experimental group and 10 in the control group) found no evidence that adaptation to head movements in the yaw plane transfers to head movements in the pitch plane, indicating that the brain adapts to vestibular stimuli in a plane-specific manner.

These findings suggest that for effective adaptation to cross-coupled stimuli, such as those experienced in spaceflight, astronauts will need to practice head movements in all planes and directions, rather than relying on adaptation from one plane to another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular adaptation to centrifugation does not transfer across planes of head rotation. Garrick-Bethell, I., Jarchow, T., Hecht, H., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8920012/

Vestibular Rehabilitation for Peripheral Vestibular Hypofunction There is strong evidence supporting vestibular physical therapy for reducing symptoms, improving gaze and postural stability, and improving function in ...

2. physio-pedia.com physio-pedia.com/Vestibular_Treatment

Vestibular Treatment Adaptation exercises are aimed at “inducing long-term changes in the neuronal response of the vestibular system to a specific error signal – retinal slip.” ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/B9780444634375000133

Chapter 13 - An overview of vestibular rehabilitation Vestibular rehabilitation has been shown to be an effective treatment for patients with dizziness and balance disorders.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12292577/

The Neural Mechanisms of Visual and Vestibular Interaction in ... The results showed that, when visual coherence was higher, the subjects' heading perception tended to favor the visual direction. As visual ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.868144/full

Heading Direction Is Significantly Biased by Preceding ... Results: A significant bias in heading into the direction of the previous roll-tilt position was observed in the post-adaptation trials. This ...

6. withpower.com withpower.com/trial/phase-vestibular-diseases-8-2020-92ac7

Motion Perception Study for Vestibular Disorders This N/A medical study run by University of Rochester is evaluating whether Heading direction adaptation will have tolerable side effects & efficacy for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12347945/

The Role of Vestibular Physical Therapy in Managing ... Conclusions: VPT may improve dizziness and balance in PPPD, though evidence is limited. Further high-quality trials with standardized protocols ...

8. mdpi.com mdpi.com/2227-9032/13/5/492

Updated Views on Vestibular Physical Therapy for Patients ... Adaptation involves prolonged adjustments in the vestibular system's neuronal firing rate in response to head movements, aiming to minimize retinal slip [20].