Mal de Debarquement SyndromeEarly Phase 1WAVESMdDSNCT04612010
WAVES for Mal de Debarquement Syndrome
A Early Phase 1 study testing WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation) in people with Mal de Debarquement Syndrome, run by University of Minnesota.
Trial summary
This study will be recruiting individuals with Mal de Debarquement Syndrome (MdDS), a disorder caused by entrainment to oscillating motion that leads to persistent oscillating vertigo. The typical triggers for MdDS are sea and air travel. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mal de Debarquement Syndrome
- What is being tested?
- WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Persistent oscillating vertigo that occurs within 48-hours of disembarking from a moving vessel such as a boat, car, or plane, 2. Symptoms improve with exposure to passive motion, 3. No other cause for symptoms after evaluation by a neurologist or otolaryngologist.
Who cannot join
- 1. History of epilepsy. 2. Structural brain injury such as stroke, brain tumor, or confluent white matter lesions. 3. Unstable medical or psychiatric condition. 4. Pregnant or planning to become pregnant during the study duration. 5. Not able to comply with all study procedures.
About this study
Official title: WAVES: Wobble-oscillator Auditory/Visual Excitatory Stimulation for Mal de Debarquement Syndrome
This study will be recruiting individuals with Mal de Debarquement Syndrome (MdDS), a disorder caused by entrainment to oscillating motion that leads to persistent oscillating vertigo. The typical triggers for MdDS are sea and air travel. Prior studies on MdDS have shown that functional connectivity measured by both EEG and fMRI decreases when symptoms of MdDS improve. This study seeks to use asynchronous visual and auditory stimulation provided through a smart-phone app (WAVES) administered through virtual reality goggles to modulate the vertigo in MdDS with the hypothesis that these stimuli can desynchronize functional connectivity.
Read the detailed description
The main device class used in this study will be an app that was designed by one of the investigators. The app is called "WAVES" and can be run on either an Android or iOS platform. The program presents a split screen of flashing lights with a different frequency on each half screen. The frequency of the lights can be changed according to either standard parameters or parameters set by EEG metrics. Audio stimulation will also be added in a second phase of the study. The audio stimulation consists of clicks given to each ear at different frequencies.
The study will have several stages. The participants will be told what stage of the project they will be participating in.
Stage 1: Open-label feasibility-this stage will include about 10-15 individuals who will be test participants for new protocols. This may include change in frequency of stimulation around a new baseline such as the individual theta frequency or the individual alpha frequency. All session parameters will be restricted, e.g. no more than 40-minutes of total stimulation per session.
Stage 2: Sham controlled single-blind randomized onsite. This stage will include participants who receive up to 40-minutes of visual stimulation given either through a protocol determined in Stage 1 as an effective paradigm or as random frequency stimulation. The participants will be blinded to study allocation. The principal investigator will not be blinded in order to have tighter oversight on safety.
Stage 3: Sham controlled double-blind randomized at home with cross over study. This stage will involve sending the participants home with a smartphone app and pre-fitted head mounted virtual reality frame. The participants will receive a kit that contains the accessories and smartphone. Allocation will be 1:1 real to sham stimulation. After a preset trial duration (generally 2-weeks) the participants who were give sham stimulation will be cross-overed to real stimulation. The individuals who underwent real stimulation will be cross-overed to sham stimulation for 2 weeks. Both will then be given the option of doing 2 weeks of open label stimulation and then tapered to off over 2 weeks. This will provide an assessment of stimulation efficacy of 2 weeks vs 4 weeks as well as the sham response rate. Each week of sessions entails 5-10 sessions per week.
The participants will be completing online study questionnaires through a personalized weblink on RedCap or SurveyMonkey.
EEG recordings will be made at baseline, conclusion, and in between sessions to monitor the correlation between symptoms and EEG features.
- Conditions
- Mal de Debarquement Syndrome
- Being tested
- WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)
- Medical subject headings
- Mal de debarquement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)Device
Also called WAVES
An app-based stimulation program administered that provides desynchronizing visual and auditory stimulation. The frequency of the stimulation oscillates around the baseline frequency determined by EEG.
| Study group | Role | What they receive |
|---|---|---|
| Alpha frequency | Active comparator | Wobble oscillation will revolve the individual alpha frequency Receives: Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation) |
| Alpha frequency plus | Active comparator | Wobble oscillation will revolve the individual alpha frequency plus 0.5Hz Receives: Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation) |
| Theta frequency | Sham comparator | Wobble oscillation will revolve the individual theta frequency Receives: Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MdDS Balance Rating Scale (MBRS)
This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function. The scale goes from 1 to 10 with 1 representing no feeling of motion and 10 representing motion severity so strong that standing is not possible.
Measured: 5 years
Secondary outcomes (3)
Visual Analogue Scale
100 point scale of global assessment of MdDS related symptoms. This scale goes from 0 to 100 with 0 representing no symptoms attributable to MdDS at all and 100 representing global symptom severity due to MdDS so severe that one is completely not functional. This scale takes into account the other symptoms of MdDS besides the feeling of motion. These other symptoms could be cognitive slowing, fatigue, visual motion intolerance, headache, and anxiety.
Measured: 5 years
Hospital Anxiety Depression Scale
A 14 item inventory of depression and anxiety symptoms that has separate items that assess depression and anxiety. Each item has a maximum of 3 possible points with higher values representing higher symptom severity. There are 21 possible points for depression and 21 possible points for anxiety.
Measured: 5 years
Dizziness Handicap Inventory
This is a standardized assessment of dizziness with items inquiring about physical, emotional, and functional elements. There are 25 questions that can each be scored up to 4 points with higher scores representing more severe symptoms.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Mar 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Hypothesis change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mal de Debarquement SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The participants will be in an n-of-1 design with each participant receiving each frequency of stimulation in a randomized blinded order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoon-Hee Cha, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612010
- Sponsor's protocol ID
- NEUR-2020-29419
- Acronym
- WAVESMdDS
- Status last verified
- May 2023
- First submitted
- 26 Oct 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and de-identified data may be shared with through an institutional data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WAVES: Wobble-oscillator Auditory/Visual Excitatory Stimulation for Mal de Debarquement Syndrome
- ClinicalTrials.gov ID
- NCT04612010
- Acronym / sponsor ID
- WAVESMdDS / NEUR-2020-29419
- Conditions
- Mal de Debarquement Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hypothesis change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be recruiting individuals with Mal de Debarquement Syndrome (MdDS), a disorder caused by entrainment to oscillating motion that leads to persistent oscillating vertigo. The typical triggers for MdDS are sea and air travel. Prior studies on MdDS have shown that functional connectivity measured by both EEG and fMRI decreases when symptoms of MdDS improve. This study seeks to use asynchronous visual and auditory stimulation provided through a smart-phone app (WAVES) administered through virtual reality goggles to modulate the vertigo in MdDS with the hypothesis that these stimuli can desynchronize functional connectivity.
Detailed description
The main device class used in this study will be an app that was designed by one of the investigators. The app is called "WAVES" and can be run on either an Android or iOS platform. The program presents a split screen of flashing lights with a different frequency on each half screen. The frequency of the lights can be changed according to either standard parameters or parameters set by EEG metrics. Audio stimulation will also be added in a second phase of the study. The audio stimulation consists of clicks given to each ear at different frequencies.
The study will have several stages. The participants will be told what stage of the project they will be participating in.
Stage 1: Open-label feasibility-this stage will include about 10-15 individuals who will be test participants for new protocols. This may include change in frequency of stimulation around a new baseline such as the individual theta frequency or the individual alpha frequency. All session parameters will be restricted, e.g. no more than 40-minutes of total stimulation per session.
Stage 2: Sham controlled single-blind randomized onsite. This stage will include participants who receive up to 40-minutes of visual stimulation given either through a protocol determined in Stage 1 as an effective paradigm or as random frequency stimulation. The participants will be blinded to study allocation. The principal investigator will not be blinded in order to have tighter oversight on safety.
Stage 3: Sham controlled double-blind randomized at home with cross over study. This stage will involve sending the participants home with a smartphone app and pre-fitted head mounted virtual reality frame. The participants will receive a kit that contains the accessories and smartphone. Allocation will be 1:1 real to sham stimulation. After a preset trial duration (generally 2-weeks) the participants who were give sham stimulation will be cross-overed to real stimulation. The individuals who underwent real stimulation will be cross-overed to sham stimulation for 2 weeks. Both will then be given the option of doing 2 weeks of open label stimulation and then tapered to off over 2 weeks. This will provide an assessment of stimulation efficacy of 2 weeks vs 4 weeks as well as the sham response rate. Each week of sessions entails 5-10 sessions per week.
The participants will be completing online study questionnaires through a personalized weblink on RedCap or SurveyMonkey.
EEG recordings will be made at baseline, conclusion, and in between sessions to monitor the correlation between symptoms and EEG features.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The participants will be in an n-of-1 design with each participant receiving each frequency of stimulation in a randomized blinded order.
| Arm | Type | Receives |
|---|---|---|
| Alpha frequency | Active comparator | Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)Wobble oscillation will revolve the individual alpha frequency |
| Alpha frequency plus | Active comparator | Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)Wobble oscillation will revolve the individual alpha frequency plus 0.5Hz |
| Theta frequency | Sham comparator | Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)Wobble oscillation will revolve the individual theta frequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Persistent oscillating vertigo that occurs within 48-hours of disembarking from a moving vessel such as a boat, car, or plane, 2. Symptoms improve with exposure to passive motion, 3. No other cause for symptoms after evaluation by a neurologist or otolaryngologist.
Key exclusion criteria (1 listed)
- 1. History of epilepsy. 2. Structural brain injury such as stroke, brain tumor, or confluent white matter lesions. 3. Unstable medical or psychiatric condition. 4. Pregnant or planning to become pregnant during the study duration. 5. Not able to comply with all study procedures.
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 |
|---|---|---|
| WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)Also: WAVESAn app-based stimulation program administered that provides desynchronizing visual and auditory stimulation. The frequency of the stimulation oscillates around the baseline frequency determined by EEG. | Device | Alpha frequency, Alpha frequency plus, Theta frequency |
Primary outcome
MdDS Balance Rating Scale (MBRS)
Time frame: 5 years
This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function. The scale goes from 1 to 10 with 1 representing no feeling of motion and 10 representing motion severity so strong that standing is not possible.
3 secondary outcomes
Visual Analogue Scale
Time frame: 5 years
Hospital Anxiety Depression Scale
Time frame: 5 years
Dizziness Handicap Inventory
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Yes. Study protocol and de-identified data may be shared with through an institutional data sharing agreement.
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.
Yoon-Hee Cha, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation) in people with Mal de Debarquement Syndrome, run by University of Minnesota.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
MdDS Balance Rating Scale (MBRS) (time frame: 5 years). 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 9 May 2023.