Symptoms and General Pathology

All Conditions

Neoplasms

Ear, Nose, and Throat Diseases

Nervous System Diseases

Rare Diseases

Motion Sickness

Space Motion Sickness

Neurilemmoma

Vestibular Diseases

Neuroma, Acoustic

Neuroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Cranial Nerve Diseases

Labyrinth Diseases

Labyrinthitis

Schwannoma

Acoustic Neuroma

Neuroendocrine Tumor

Neuroepithelioma

Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site.

Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method

Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness.

Typically, the suggestion for treating motion sickness once it has started is to avoid motion. Therefore, healthy control subjects that meet similar similar physical characteristics of astronauts will not receive any post motion sickness treatment.

Exercises that teaches subjects to move their heads while viewing still or moving targets.

Traditional Therapy

The SWAN device uses video-oculography to monitor head motion while guiding participants to move their head in yaw, pitch, roll planes for 15 minutes. Feedback is provided regarding frequency and plane of head rotation

SWAN

Michael Schubert, PhD

Matthew Stewart, MD PhD

Michael C Schubert, PhD

Colin R Grove, PhD

Rich Folga

Darcy Gallimore

Richard Folga

The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.

The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.

At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).

StableEyes With Active Neurofeedback

StableEyes With Active Neurophysiological Feedback

Currently, we have no plan to share data with other researchers

Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting.

Ratio of eye velocity to head velocity that varies from 0 to 1.2. Normal scores are greater than 0.8.

Increase blinking is correlated with worse motion sickness.

Heart rate in beats per minute will be measured using a monitor worn over the forearm.

Time measured in seconds for a subject to stand up, step over an obstacle then walk 3M before turning around and sitting down.

Time in seconds to stand on foam with eyes open. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.

Time in seconds to stand on foam with eyes closed. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.

Time to seconds to stand on foam with eyes open while moving head up and down. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.

Time in seconds to stand on foam with eyes closed while moving head up and down. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.

Velocity to walk 6m within a 10m marked distance, measured in meters/second. Normative data exists based on decade of age.

Distance walked in 2 minutes, measure in meters.

Vertical alignment nulling and torsional alignment nulling ask subjects to adjust lines to there perceived horizontal. Measured in degrees.

Subjects adjust a virtual line to their perceived vertical, measured in degrees.

Subjects wear an activity monitor on their wrist Data includes daily distance walked .

National Aeronautics and Space Administration (NASA)

Johns Hopkins University

Behaviors and Mental Disorders

Anxiety Disorders

Head and Neck Neoplasms

Lay in treatment position for 20 minutes with surface monitoring technology activated

Mask-free headrest and couch for patient positioning for radiation therapy combined with a surface monitoring system

Mask-free surface monitoring

Paul Keall, Prof

Natalie Plant, MHSc

Suganthy Varadarajan

Tracy Pearl-Larsson

Purmina Sundaresan, Dr

A pilot-stage device feasibility study investigating a mask-free motion-monitoring patient immobilisation system for use during radiation therapy treatment of head and neck cancer (HNC). This mask-free system combines the standard radiation therapy (RT) head rest to help the patient remain still with a surface guidance detection system that uses sensors to detect and track patient movement.

Patients who will have RT treatment for head and neck cancer involving an immobilisation mask will be asked to lie on the treatment couch for the normal treatment fraction time while the surface monitoring system is activated. We will then assess:

i) The level of acceptance of the system by HNC patients currently being treated with RT using an immobilisation mask, and ii) The ability of the surface guidance system to monitor movement of the patients

Radiation therapy (RT) is a central treatment modality for 74% of head and neck cancer (HNC) patients where preservation of the form and function of localised organs and tissue is of prime importance. Radiation therapy offers the possibility of organ preservation by providing a non-surgical approach to curative treatment, while helping to limit the extent of surgery in cases where definitive surgery is unavoidable. Radiation therapy also has an important role in maintaining quality of life in the palliative management of incurable HNC, where it can prevent and alleviate pain, bleeding, tumour fungation and difficulty with swallowing, breathing and speech.

State-of-the-art RT for HNC delivers lethal radiation doses to the cancer while sparing vital organs situated just a few millimetres away. To achieve this level of accuracy, tight-fitting thermoplastic head and neck masks are used to immobilise the patient in the desired treatment position for the duration of each of their RT treatments. These thermoplastic immobilisation devices are accepted internationally as the necessary standard and included in published guidelines. Open masks are an emerging immobilisation measure and a first step to reduce patient discomfort and anxiety. An open mask has a smaller visual restriction and fewer restraint points.

Although, thermoplastic immobilisation masks are the accepted clinical standard for HNC RT, it is widely recognised and acknowledged that there are several limitations with their use. Changes to the mask's fit may be needed due to patient weight loss, tumour shrinkage, or treatment related oedema. Thus, radiation therapists are required to monitor the mask for fit throughout the treatment course, undertake imaging at regular intervals and make corrections as per published guidelines and local protocols. There is also risk of movement of the patient within the mask, which may lead to under dosing of the target and overdosing of organs at risk. Court et al. reported that patients in their study needed to be repositioned in the immobilisation mask before treatment for 14% of fractions; 30% of the repositioning was for shoulder shifts of 1 cm or greater. Neubauer et al. observed shoulder motion of 2-5 mm in each direction on average (20 mm max). These shifts resulted in coverage loss (dose to 99% of the clinical target volume decreased by up to 1Gy) or increased dose to organs at risk (e.g., dose to brachial plexus increased by 0.7Gy).

The ACRF Image X Institute at the University of Sydney has developed a novel surface guidance system that can be mounted to any RT imaging and treatment couch. This system is currently being used in a clinical trial (NCT02881203) to guide breast cancer patients into a reproducible breath hold: the patient's chest position is measured via surface imaging and the system delivers visual feedback to the patient via a screen for the patient to correct their breath hold level if necessary (i.e., surface guidance). This system uses off-the-shelf electronics, most importantly a sensor which includes an optical and a depth camera, delivering frames at a rate of 30Hz and allowing the patient and operator to see an augmented reality video feed, including the surface depth information.

Similar to this, we will apply optical and depth cameras for head and neck surface monitoring by integrating a second sensor and adapting it to the different location of treatment

Pilot-stage, single-arm study investigating the technical feasibility and patient acceptance of a non-interventional, non-invasive, mask-free surface detection system.

Towards the end of their scheduled radiation therapy treatments, people being treated for HNC with RT using a thermoplastic immobilisation mask will be asked to lie in a treatment position on a treatment couch using a standard radiation therapy headrest without the mask, for the normal amount of time taken for individual radiation therapy treatments (20 minutes). During this time, the mask-free surface detection system will detect and record their location and movement. Data collected by the surface detection system during this couch session will be analysed to determine the feasibility of using the equipment to detect location and movement over this period. Data collected directly from the participants immediately before, during and following the couch session will be used to determine their acceptance of the system in terms of comfort and anxiety when compared with wearing the mask, and any suggestions for improvement of the system. Data collected directly from the radiation therapists following the couch session will be used to investigate their thoughts on the abilities of the system, ease of use and suggestions they may have.

To investigate the effect of changes in appearance due to weight loss over the course of HNC radiation therapy treatment, a 5-minute surface monitoring couch session conducted before the start of radiation therapy will record baseline surface-monitoring information only.

Data analysis will occur at the University of Sydney outside of participant sessions.

This is a hypothesis-producing feasibility study that does not involve power calculations. The number of participants (20) was chosen to enable confidence in the primary outcome calculation.

Surface Monitoring Technology to Remove The Mask - Stage 1

Non-identifiable individual participant data (IPD) may be shared with researchers for further scientific research. Facial images/photos identifying participants will not be shared.

Technical feasibility of surface-monitoring system in ≥90% of consumers - operates continuously throughout the session and provides information on the position and motion of the cranium, mandible and shoulders without obvious erroneous results or faults

Patients complete the session AND give a mean score of 4 or more for both comfort and acceptability on a Likert scale of 1-7, where 1 = 'Very Strongly Disagree' and 7 = 'Very Strongly Agree'

Qualitative semi-structured interview of patient experience of interacting with the surface monitoring system and how that compared with the experience of the immobilisation mask during their radiation therapy treatment.

Questionnaire of radiation therapist's experience scored according to a Likert scale of 1-5 where 1 = 'Strongly Disagree' and 5 = 'Strongly Agree'

Distance and direction of, and correlation between, motion of the cranial and upper torso anatomy relative to the fixed isocentre

Distance and direction of, and correlation between, motion of the cranial and upper torso anatomy relative to first image taken

Change in number of detection of points in the point cloud in response to residual motion of anatomical landmarks over 20 minutes of continuous data acquisition

A photograph taken by the system camera showing physical characteristics of face and hair (e.g. shape, tone, location, size)

The effect of change in weight (kg) from pre-RT to late RT on Outcome 5

The effect of change in weight (kg) from pre-RT to late RT on Outcome 6

Western Sydney Local Health District

University of Sydney

Migraine Disorders

Vertigo

Dizziness

Headache

Headache Disorders

Headache Disorders, Primary

Brain Diseases

Central Nervous System Diseases

Sensation Disorders

Neurologic Manifestations

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

The investigators will characterize vestibular spatial and temporal precision by calculating perceptual thresholds and reaction times for vestibular (yaw rotation, ytranslation) stimuli in normal subjects over a wide age range. Vestibular-visual temporal binding is then performed on each subject and the relationship between the principal parameters (vestibular perceptual thresholds \[inversely related to spatial precision\], vestibular reaction time variability \[inverse of temporal precision\], and the PSS and TBW from the temporal binding paradigm) will be examined. The investigators will collect qualitative assessments of dizziness/disbalance (DHI: dizziness handicap index) and quantitative measurements of balance and vestibular function (FGA: functional gait analysis, postural sway, and standard rotational testing - VOR gain, time constant, asymmetry).

Migraine and Vestibular Migraine patients

The investigators intend to evaluate vestibular (yaw rotation or y-translation) - visual temporal binding in people with a wide range of motion sickness sensitivities (as quantified with standard questionnaires), including normal subjects, people with migraine and with vestibular migraine. The investigators will use our standard adaption method to narrow the TBW in these subjects, and will also employ PSS adaptation if a consistent pattern emerges that relates MS sensitivity to the PSS. The investigators will induce motion sickness using a pseudo-Coriolis task (so susceptibility can be quantified pre and post training).

Vestibular Schwannoma patients

The basic approach is to characterize the precision of their vestibular information (perceptual thresholds for spatial precision, reaction times for temporal precision), and their temporal binding characteristics for vestibular (yaw rotation or y-translation)-visual inputs, in three states: pre-op, sub-acute post-op (2-6 weeks), and chronic post-op (6 months+). At each state the investigators will also assess the quality of their vestibular-mediated behaviors through questionnaires (e.g. DHI), postural sway, functional gait analysis, and standard rotational testing (VOR gain, time constant, and asymmetry).

Cochlear Implant (CI)/Vestibular Implant (VI) patients

A causative role for vestibular precision in temporal binding will be investigated in the VI patients, since the noise characteristics of the vestibular channel will be varied and to determine how this affects thresholds and temporal binding. As part of a second aim, the investigators will use VI and CI prosthetic signals in patients who have never received them together to see how the brain process sensory cues to which it is essentially naïve. Finally, after the acute experiments the investigators will provide 8 hours of 'physiologic' VI and CI stimulation by turning both implants on, sound modulates activity in the CI as usual, and angular head motion modulates activity in the VI while the subject actively explores the hospital environment.

The investigators will use a temporal order judgment (TOJ) with a visual (light) cue and a motion (yaw rotation, y-translation) cue. The relative timing of the motion onset and the light are varied and subjects indicate which occurred first by pressing a button after the motion ends. The TOJ task will generate a psychometric curve and the PSS (point of subjective simultaneity) and TBW (temporal binding window) are calculated. Then training focuses on SOAs (stimulus onset asynchronies) near the TBW borders (e.g., PSS +/- 0.5xTBW), starting from 50 ms outside the TBW and moving randomly towards the PSS. The goal of the training is to narrow the TBW -- training trials will be provided for 30 min and after each response the subject is told if their response was right or wrong. After training, the TOJ task is repeated to determine how the TBW has changed. Sham training will be the same as the actual training except that verbal feedback of response accuracy will not be provided.

Temporal Binding Adaptation - TBW training

After the PSS and TBW are calculated with the standard TOJ paradigm, 100 training trials are provided where the SOA is set to \[PSS - 200 ms\], with the goal of shifting the PSS more negative. Then the TOJ task will be repeated but every 10 testing trials will be followed by 10 training trials (SOA = PSS - 200), and this pattern will be repeated 10 times to 100 more training trials interspersed with the Post TOJ data. Subjects will respond after all trials and testing and training will not be distinguished. After this is completed, the new PSS and TBW are calculated. Sham PSS training will be identical to the above except that the 'training' period will consist of random SOAs rather than a series of fixed SOAs.

Temporal Binding Adaptation - PSS training

The adaptation will utilize the same approach used in non-implanted patients. The investigators will provide a repeated, fixed SOA with either the CI or VI leading the other stimulus by 220 ms. After the training period, which will match the number of stimuli pairs provided to our normal vestibular-auditory control subjects undergoing PSS adaptation, the TOJ study is repeated to recalculate the PSS and TBW.

Temporal Binding Adaptation - PSS adaptation with VI stimulation

To provide 8 hours of 'physiologic' CI and VI inputs during normal activities, the investigators will employ standard motion-modulated stimulation with the VI. This requires pre-adaptation to a 200 pps tonic stimulation rate (to emulate the push-pull design of the native vestibular system allowing modulating stimulation upward or downward with opposite directions of motion). The three electrodes are connected to the head-mounted prosthetic circuit, which consists of three angular velocity sensors (one aligned with the sensitive axis of each canal) such that head rotations in the plane of the given canal modulate the stimulation rate of the corresponding electrode, upward (for ipsi) or downward (for contralateral) head rotations, thereby simulating normal canal-mediated modulations.

Chronic Motion-modulated Stimulation

Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. The temporal binding of vestibular and non-vestibular sensory cues is poorly understood and has not been studied in detail, despite the fact that the vestibular system operates in an inherently multimodal environment. In this study, the researchers are investigating the physiology and pathophysiology of vestibular temporal binding by studying normal subjects, patients with peripheral and central vestibular dysfunction, and patients with vestibular and cochlear signals provided by prosthetic implants in the inner ear.

Multiple sensory cues are generated by discrete events (e.g., the vestibular-visual signals after hitting a pothole) and while they do not reach the cerebrum simultaneously, the brain can synthesize them if they are interpreted as corresponding to a single event. This is critical because the central representation of an event is improved if two or more relevant cues are integrated but conversely is degraded if unrelated inputs are synthesized. Little research has focused on temporal binding of vestibular signals with other sensory cues, even though the vestibular system operates in an inherently multimodal environment, and virtually nothing is known about temporal binding abnormalities in patients with peripheral or central vestibular disorders. The investigators will use psychophysical tests (quantifying the PSS \[point of subjective simultaneity\] and TBW \[temporal binding window\]) to study vestibular temporal binding in normal people, patients with combined vestibular and cochlear prostheses, and patients with peripheral or central vestibular dysfunction. The researchers will investigate two fundamental aspects of temporal binding: its dependence on signal precision and adaptation driven by habitual exposure to sensory patterns. Furthermore, the researchers will investigate how and why temporal binding differs from normal in patients with peripheral and central vestibular dysfunction.

Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma

Temporal Synthesis of Vestibular and Extra-Vestibular Sensory Signals

Measurements of postural sway during Romberg testing on floor and foam (including an extra 60s balance test during which subject stands on foam and shakes head left and right at 1hz frequency while fixating on a point a set distance away) pre \& post temporal binding adaptation (TBW \& PSS training).

This measure is scored before and after PSS and TBW adaptation in UVD (unilateral vestibular dysfunction) patients. Gait is scored by performance on a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

Looking at the change between before and after PSS and TBW adaptation in UVD (unilateral vestibular dysfunction) patients. Inducible dizziness is the symptom severity provoked by a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

The investigators will use a well-validated variant of the classic Coriolis task, a pseudo-Coriolis task where subjects view a strong yaw-axis OKN stimulus while the head is tilted passively in roll at 1.0 Hz (starting 5 s after the vection illusion begins). The investigators found empirically that 40 roll tilts of the head were adequate to induce a range of MS symptoms, from virtually none in people with minimal MS sensitivity to severe nausea in people with more prominent MS sensitivity. Subjects grade their MS symptoms before and after the pseudo-Coriolis task using a simple visual analog (0 to 10) scale.

Pre and post chronic motion-modulated stimulation in CI/VI patients - the PSS will be measured during temporal binding testing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
StableEyes With Active Neurofeedback	NCT05622344	Vestibular Diso... Vestibular Schw... Space Motion Si... Motion Sickness	Traditional The... SWAN	21 Years - 70 Years	Johns Hopkins University
Surface Monitoring Technology to Remove The Mask - Stage 1	NCT04266223	Head and Neck C... Radiation Thera... Anxiety	Mask-free surfa...	18 Years -	University of Sydney
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma	NCT04196933	Migraine Vestibular Migr... Vestibular Schw... Motion Sickness Dizziness Vestibular Diso...	Temporal Bindin... Temporal Bindin... Temporal Bindin... Chronic Motion-...	8 Years - 80 Years	Massachusetts Eye and Ear Infirmary
StableEyes With Active Neurofeedback	NCT05622344	Vestibular Diso... Vestibular Schw... Space Motion Si... Motion Sickness	Traditional The... SWAN	21 Years - 70 Years	Johns Hopkins University
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma	NCT04196933	Migraine Vestibular Migr... Vestibular Schw... Motion Sickness Dizziness Vestibular Diso...	Temporal Bindin... Temporal Bindin... Temporal Bindin... Chronic Motion-...	8 Years - 80 Years	Massachusetts Eye and Ear Infirmary

Spots Global Cancer Trial Database for motion sickness