DizzinessNCT04420949
Sensory Training for Visual Motion Sickness
A study testing Sensory re-weighting in people with Dizziness and Vertigo, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a preliminary study to determine the reliability and validity of new tests of orientation and balance, as well as to test the effects of a new treatment for visually induced dizziness. Tests involve determining vertical alignment. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dizziness, Vertigo, Motion Sickness
- What is being tested?
- Sensory re-weighting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have normal self-reported cognitive function
- speak English fluently
- weigh less than 225 pounds and be less than 6'4"
- be able to support their body weight in an upright posture for 15 minutes at a time
- be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in this protocol
- have self-reported symptoms of visually-induced dizziness
Show all 11Show fewer
- have normal self-reported cognitive function
- speak English fluently
- weigh less than 225 pounds and be less than 6'4"
- be able to support their body weight in an upright posture for 15 minutes at a time
- be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in this protocol
Who cannot join
- be pregnant or planning to become pregnant while in "on study" status
- have best-corrected visual acuity > 20/70
- have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
- have peripheral neuropathy
- have a self-reported history of frequent syncope (>1/month)
- Participants with Visually-induced Dizziness:
Show all 10Show fewer
- be participating in vestibular and balance rehabilitation therapy and/or be pregnant or planning to become pregnant while in "on study" status
- have best-corrected visual acuity > 20/70
- have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
- have peripheral neuropathy, and/or 5) have a self-reported history of frequent syncope (>1/month)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: High-precision Immersive Robotic Environment for Sensorimotor Training
This is a preliminary study to determine the reliability and validity of new tests of orientation and balance, as well as to test the effects of a new treatment for visually induced dizziness. Tests involve determining vertical alignment. The treatment is task-based and involves focusing attention on internal body sensations to help improve the sense of upright. Testing is done twice before and twice after treatment, which is provided twice-weekly during a three-week period between testing. The total time participants are involved in the study is approximately six weeks.
Read the detailed description
Falls are a major concern for people living in countries all over the world. Tens of millions of people who fall are seriously injured and hundreds of thousands of people who fall die every year. People who are dizzy are far more likely to fall. The investigators are particularly interested in working with people who have dizziness that is caused by watching motion or looking at complex patterns (e.g. checkerboard patterns, walking through grocery store aisles, riding in vehicles, or watching movies).
This type of dizziness or vertigo is typically described as motion sickness or, more specifically, visually-induced dizziness. This problem affects adults who are healthy and adults who have a variety of health conditions. No diagnostic tests for this condition exist at this time and the treatments currently being used may result in worsening dizziness for some patients.
New tests were created for orientation and balance, as well as a new treatment for visually-induced dizziness. This is a preliminary study of the reliability and validity of the tests we developed, as well as whether the new treatment created results in reduced dizziness, improved balance, and changes in daily functioning.
It is not known whether the new tests of orientation and balance are better, worse, or the same as existing tests in the ability to detect problems, nor is it known if the new treatment technique is any better, worse, or the same as existing treatments for dizziness and imbalance. It is hypothesized that the new tests will be accurate and able to detect problems in impaired adults. Additionally, that the treatment will result in less dizziness, better balance, and reduced risk of falling.
The plan is to enroll a total of 30 people in this study, 15 who are healthy and 15 who have visually-induced dizziness due to a vestibular (inner ear) problem. Each participant will complete several questionnaires and tests of balance performance before and after undergoing the treatment. Participants attend 8 visits over 6 weeks. Each study visit lasts approximately 60 minutes.
During visits 1 and 2, which is a double baseline phase, the reliability and validity of the new testing procedures will be assessed. All participants will then enter the treatment phase (visits 2 through 7) and will attend twice-weekly appointments for three consecutive weeks. Following the treatment phase, participants will be re-assessed twice, immediately after (visit 7) and one week after (visit 8) completing treatment. During this phase, the short-term effectiveness of the treatment will be assessed.
Participants will complete questionnaires that measure the intensity of visually-induced dizziness, perceived handicap due to dizziness, and the impact of dizziness on daily functioning. Performance measures include the ability to determine what is upright based on the internal sense of gravity (verticality), standing upright, and walking-related balance tasks. The verticality tests are performed while the participant is secured in a harness and are either standing upright or tilted to the left or to the right. The testing task is to determine upright based on using internal body sensations. The standing balance test is performed on a platform that measures balance. The verticality tests and the standing balance test are experimental.
The treatment is task-based and is performed while the participant is supported in a harness and wearing virtual reality goggles. During the treatment, participants are either standing upright or tilted to the left or to the right. The treatment involves focusing attention on internal body sensations to help determine whether an image that is presented in an otherwise black virtual environment is aligned with gravity. Other visual and sound cues will be eliminated to prevent the use of these cues from influencing decisions about what is upright. As the participant becomes more successful at determining what is upright, the difficulty of the treatment task is gradually increased.
Participants symptoms will be monitored throughout the testing and treatment. Participants are given regular rest breaks and may request to rest at any time. Participation is voluntary and may be discontinued at any time.
The investigators anticipate only mild and infrequent side effects related to testing and treatment. The results of this study may influence how orientation and balance are assessed and how visually-induced dizziness is treated.
- Conditions
- Dizziness, Vertigo, Motion Sickness
- Being tested
- Sensory re-weighting
- Keywords
- verticality, postural balance, visual dependence
- Medical subject headings
- Dizziness, Vertigo, Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory re-weightingBehavioural
During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Healthy adults with visually-induced dizziness with undergo the testing and treatment. Receives: Behavioral: Sensory re-weighting |
| Vestibular-impaired | Experimental | Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment. Receives: Behavioral: Sensory re-weighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rod and Disk Test (RDT) Mean Performance
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.
Measured: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
This test is designed to assess balance during quiet standing in different sensory conditions. Participants perform one trial (lasting 30 seconds) of each condition. All trials are performed while standing on a force plate with the feet in a self-selected, comfortable position. The visual environment is controlled using an Oculus Rift. The surface conditions are either non-compliant or compliant. The frequency-dependent height of the Intersection Point (IP) of the ground reaction force is the main metric. The overall height of the IP curve obtained while the participant stands on a firm surface with their eyes open is the primary outcome. The height of IP ranges from 0 to 4.0, and higher values represent greater stability.
Measured: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Subjective Visual Vertical (SVV) Mean Performance
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.
Measured: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Rod and Frame Test (RFT) Mean Performance
An image of a rod will be projected inside a tilted frame within the central portion of the visual field. The surrounding virtual environment will be void. The frame will be tilted by +/- 20° in the frontal plane. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, mean performance in this population is 6.51 (sd 7.8). Higher values indicate greater deviations of perceived vertical from earth vertical.
Measured: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Secondary outcomes (2)
Vision-related Dizziness Questionnaire (VRDQ) Total Score
The VRDQ is used to quantify vision-related dizziness. This outcome measure consists of 25 questions comprising two subscales [frequency and severity of symptoms]. The range of scores for each sub-scale is 0 to 100 points. The total score is the average of both sub-scales. Higher scores represent greater frequency and severity of symptoms. Test-retest reliability for the VRDQ is well above the good performance level and convergent validity for the VRDQ was demonstrated with the Dizziness Handicap Inventory (DHI). Spearman correlation coefficients are 0.75 between the DHI and VRDQ frequency scale and 0.76 between the DHI and VRDQ severity scale.
Measured: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Dizziness Handicap Inventory (DHI) Total Score
The DHI is used to assess the severity of self-perceived disability secondary to dizziness. The tool is comprised of 25 questions which are score as yes = 4 points, sometimes = 2 points, and no = 0 points. The total score has a range of 0 to 100 points. The reliability and validity of the DHI have been established.
Measured: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start19 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in three phases. The first phase is for baseline testing. The second phase is when treatment occurs. The third phase is for follow up testing. Participants will be tested twice during the baseline and follow up phases. Six treatment sessions will occur during the treatment phase.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420949
- Sponsor's protocol ID
- 2020-0632
- Other IDs
- A176000, EDUC/KINESIOLOGY, Protocol Version 5/1/2020, 1UL1TR002373-01
- Status last verified
- May 2023
- First submitted
- 15 May 2020
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-precision Immersive Robotic Environment for Sensorimotor Training
- ClinicalTrials.gov ID
- NCT04420949
- Acronym / sponsor ID
- 2020-0632
- Conditions
- Dizziness, Vertigo, Motion Sickness
- Keywords
- verticality, postural balance, visual dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a preliminary study to determine the reliability and validity of new tests of orientation and balance, as well as to test the effects of a new treatment for visually induced dizziness. Tests involve determining vertical alignment. The treatment is task-based and involves focusing attention on internal body sensations to help improve the sense of upright. Testing is done twice before and twice after treatment, which is provided twice-weekly during a three-week period between testing. The total time participants are involved in the study is approximately six weeks.
Detailed description
Falls are a major concern for people living in countries all over the world. Tens of millions of people who fall are seriously injured and hundreds of thousands of people who fall die every year. People who are dizzy are far more likely to fall. The investigators are particularly interested in working with people who have dizziness that is caused by watching motion or looking at complex patterns (e.g. checkerboard patterns, walking through grocery store aisles, riding in vehicles, or watching movies).
This type of dizziness or vertigo is typically described as motion sickness or, more specifically, visually-induced dizziness. This problem affects adults who are healthy and adults who have a variety of health conditions. No diagnostic tests for this condition exist at this time and the treatments currently being used may result in worsening dizziness for some patients.
New tests were created for orientation and balance, as well as a new treatment for visually-induced dizziness. This is a preliminary study of the reliability and validity of the tests we developed, as well as whether the new treatment created results in reduced dizziness, improved balance, and changes in daily functioning.
It is not known whether the new tests of orientation and balance are better, worse, or the same as existing tests in the ability to detect problems, nor is it known if the new treatment technique is any better, worse, or the same as existing treatments for dizziness and imbalance. It is hypothesized that the new tests will be accurate and able to detect problems in impaired adults. Additionally, that the treatment will result in less dizziness, better balance, and reduced risk of falling.
The plan is to enroll a total of 30 people in this study, 15 who are healthy and 15 who have visually-induced dizziness due to a vestibular (inner ear) problem. Each participant will complete several questionnaires and tests of balance performance before and after undergoing the treatment. Participants attend 8 visits over 6 weeks. Each study visit lasts approximately 60 minutes.
During visits 1 and 2, which is a double baseline phase, the reliability and validity of the new testing procedures will be assessed. All participants will then enter the treatment phase (visits 2 through 7) and will attend twice-weekly appointments for three consecutive weeks. Following the treatment phase, participants will be re-assessed twice, immediately after (visit 7) and one week after (visit 8) completing treatment. During this phase, the short-term effectiveness of the treatment will be assessed.
Participants will complete questionnaires that measure the intensity of visually-induced dizziness, perceived handicap due to dizziness, and the impact of dizziness on daily functioning. Performance measures include the ability to determine what is upright based on the internal sense of gravity (verticality), standing upright, and walking-related balance tasks. The verticality tests are performed while the participant is secured in a harness and are either standing upright or tilted to the left or to the right. The testing task is to determine upright based on using internal body sensations. The standing balance test is performed on a platform that measures balance. The verticality tests and the standing balance test are experimental.
The treatment is task-based and is performed while the participant is supported in a harness and wearing virtual reality goggles. During the treatment, participants are either standing upright or tilted to the left or to the right. The treatment involves focusing attention on internal body sensations to help determine whether an image that is presented in an otherwise black virtual environment is aligned with gravity. Other visual and sound cues will be eliminated to prevent the use of these cues from influencing decisions about what is upright. As the participant becomes more successful at determining what is upright, the difficulty of the treatment task is gradually increased.
Participants symptoms will be monitored throughout the testing and treatment. Participants are given regular rest breaks and may request to rest at any time. Participation is voluntary and may be discontinued at any time.
The investigators anticipate only mild and infrequent side effects related to testing and treatment. The results of this study may influence how orientation and balance are assessed and how visually-induced dizziness is treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted in three phases. The first phase is for baseline testing. The second phase is when treatment occurs. The third phase is for follow up testing. Participants will be tested twice during the baseline and follow up phases. Six treatment sessions will occur during the treatment phase.
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Behavioral: Sensory re-weightingHealthy adults with visually-induced dizziness with undergo the testing and treatment. |
| Vestibular-impaired | Experimental | Behavioral: Sensory re-weightingAdults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- have normal self-reported cognitive function
- speak English fluently
- weigh less than 225 pounds and be less than 6'4"
- be able to support their body weight in an upright posture for 15 minutes at a time
- be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in this protocol
Key exclusion criteria (10 listed)
- be pregnant or planning to become pregnant while in "on study" status
- have best-corrected visual acuity > 20/70
- have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
- have peripheral neuropathy
- have a self-reported history of frequent syncope (>1/month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory re-weightingDuring training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round. | Behavioural | Healthy, Vestibular-impaired |
Primary outcome
Rod and Disk Test (RDT) Mean Performance
Time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
Time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
This test is designed to assess balance during quiet standing in different sensory conditions. Participants perform one trial (lasting 30 seconds) of each condition. All trials are performed while standing on a force plate with the feet in a self-selected, comfortable position. The visual environment is controlled using an Oculus Rift. The surface conditions are either non-compliant or compliant. The frequency-dependent height of the Intersection Point (IP) of the ground reaction force is the main metric. The overall height of the IP curve obtained while the participant stands on a firm surface with their eyes open is the primary outcome. The height of IP ranges from 0 to 4.0, and higher values represent greater stability.
Subjective Visual Vertical (SVV) Mean Performance
Time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.
Rod and Frame Test (RFT) Mean Performance
Time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
An image of a rod will be projected inside a tilted frame within the central portion of the visual field. The surrounding virtual environment will be void. The frame will be tilted by +/- 20° in the frontal plane. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, mean performance in this population is 6.51 (sd 7.8). Higher values indicate greater deviations of perceived vertical from earth vertical.
2 secondary outcomes
Vision-related Dizziness Questionnaire (VRDQ) Total Score
Time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Dizziness Handicap Inventory (DHI) Total Score
Time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory re-weighting in people with Dizziness and Vertigo, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rod and Disk Test (RDT) Mean Performance (time frame: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.