Mal de Débarquement SyndromeNCT05460520
DevRobust Treatment for Mal de Débarquement Syndrome
A study testing VOR Readaptation, VOR Habituation and Visual Motion Desensitization in people with Mal de Débarquement Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Mal de Débarquement Syndrome (MdDS) is an under-recognized balance disorder, which is manifested by persistent false sensations of oscillatory self-motion (rocking/swaying) and/or pulling in a specific direction (gravitational pull). Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Mal de Débarquement Syndrome
- What is being tested?
- VOR Readaptation, VOR Habituation and Visual Motion Desensitization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conformable diagnosis of Mal de Débarquement Syndrome including significant improvement of symptoms with passive motion.
Who cannot join
- A history of abnormal inner ear or central vestibular function indicated by abnormal nystagmography test (abnormal saccades or pursuit, VOR suppression index <85%, no caloric response, decay time constant of response to rotation less than 10 seconds, spontaneous nystagmus).
- Confounding neurological disorders (e.g., multiple sclerosis, Parkinson's, epilepsy, blindness etc.).
- A history of leg, spine, or other injuries that affect their ability to stand or walk without assisting support.
- High level of anxiety as indicated by State-Trait Anxiety Inventory (≥75) and the Beck Anxiety Inventory (≥55).
- Claustrophobia.
- Patients previously treated with VOR readaptation technique are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sergei Yakushin, PhD, (212) 241-9349, sergei.yakushin@mssm.edu
Jun Maruta, PhD, (212) 241-5611, jun.maruta@mountsinai.org
About this study
Official title: Developing Robust Treatment Options for Mal de Débarquement Syndrome
Mal de Débarquement Syndrome (MdDS) is an under-recognized balance disorder, which is manifested by persistent false sensations of oscillatory self-motion (rocking/swaying) and/or pulling in a specific direction (gravitational pull). Patients with MdDS typically experience additional presumably secondary symptoms, such as heightened sensitivity to visual motion (visually induced dizziness, VID), physical motion (motion sickness, MS), and other debilitating physical, cognitive, or affective problems. MdDS was previously considered intractable, and only recently was a breakthrough made in the clinical laboratory with an introduction of a visual-vestibular therapy protocol, yielding a significant long-term improvement of symptoms, including complete remission, in about 50% of patients. However, the approach is limited in several ways. Firstly, there is a practical limitation in implementing the treatment protocol, which requires a specialized set-up for visual stimulation in a dedicated room. This research will address this limitation by testing the utility of virtual reality technology to implement the treatment protocol. Secondly, patients often retain residual symptoms of VID and MS susceptibility, which often act as a trigger for the recurrence of MdDS. This limitation will be addressed by supplementing the original approach with an additional treatment focusing on VID or MS susceptibility. Thirdly, although the original protocol focused on reducing rocking/swaying sensations, gravitational pull often co-occurs with such sensations, and some experience only that motion sensation. This limitation will be addressed by modifying the original protocol. Two hundred patients with MdDS will be recruited for the study. Bias will be controlled by randomized group assignment and the use of placebo treatments. Patients will be treated for 1-2 hours a day for 5 days. Patients will be followed for up to 6 months. The proposed study will facilitate improved outcomes for MdDS by broadening its treatment options.
Read the detailed description
Objectives This study aims to improve outcomes of MdDS by broadening its treatment options. Specifically, to improve access to the VOR readaptation treatment, the investigators will test the efficacy of VR goggles in generating visual motion to treat MdDS. If proven to be effective, MdDS patients can be treated locally in many vestibular therapy offices, not only for initial treatment but also for remedial or follow-up treatment when symptoms return. To improve long-term outcomes of MdDS, the investigators will evaluate the efficacy of the treatment of a complementary approach combined with VOR readaptation. The investigators hypothesize that an additional intervention that reduces (habituates) the velocity storage capacity will decrease sensitivity to physical movement and improves MdDS symptoms as well as limits symptom recurrence. In addition the investigators hypothesize that desensitization to visual stimuli can reduce visually induced dizziness frequently observed in patients with MdDS. The investigators will verify whether these complementary treatments will provide a better outcome compared to the readaptation treatment by itself. Lastly, to broaden the scope of the VOR readaptation treatment, the study will address the false sensation of gravitational pull commonly reported by patients. The investigators also hypothesize that a visual motion stimulus without cross-axis head motion can reduce this sensation.
Specific Aims Specific Aim 1: Evaluate the efficacy of VR goggles for VOR readaptation. One hundred patients with oscillatory self-motion sensations will be randomly assigned to undergo VOR readaptation with full-field OKS (Group 1, n=50) or VR goggles (Group 2, n=50). Immediate and up to six-month follow-up results will be compared.
Specific Aim 2: Evaluate the efficacy of habituation and visual desensitization combined with VOR readaptation. Sixty patients with oscillatory self-motion sensations will be randomly assigned to undergo VOR readaptation with full-field OKS combined with a habituation (Group 3, n=30) or visual desensitization (Group 4, n=30) protocol. Immediate and up to six-month follow-up results will be compared to those of Group 1.
Specific Aim 3: Treatment of gravitational pull sensation. The investigators estimate that 40 of 200 patients screened for this study will have a phantom sensation dominated by gravity pull, 20 with only that sensation. These patients will be randomly assigned to undergo OKS in a full-field (Group 5, n=20) or VR setting (Group 6, n=20). Immediate and up to six-month follow-up results will be compared.
How Research Will Be Introduced to Participants:
The study will be introduced to potential participants through public announcements such as ClinicalTrials.gov, referrals from clinicians, or direct contact by investigators to individuals who previously requested to be contacted for the opportunity to participate in an MdDS treatment study.
How Participants Will Be Screened:
Informed consent form will be emailed to individuals interested in study participation. Individuals will be contacted by the investigators over the phone and consented for study participation. Consented potential participants will receive intake forms via email with questions regarding the history and symptom characteristics of MdDS, age, sex, and general medical history. Investigators will review the returned intake forms to determine eligibility for study participation based on the inclusion/exclusion criteria described separately and a telephone interview for confirmation and clarification of the candidate's MdDS symptoms. A nystagmography test will then be requested to verify normal inner ear and central vestibular functioning. When candidates do not qualify for the study, screening data will be de-identified, and only those about MdDS symptom presentation, age, sex, and the reason for exclusion will be kept. Intake form and the nystagmography report of the candidates will be securely transferred to NYU for Dr. Catherine Cho to review. Dr. Cho will then conduct a telephone interview with each candidate, and provide PI with confirmation or denial of candidate eligibility, after which the information reviewed by Dr. Cho will be destroyed.
- Conditions
- Mal de Débarquement Syndrome
- Being tested
- VOR Readaptation, VOR Habituation, Visual Motion Desensitization, Opposing visual motion stimulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOR ReadaptationBehavioural
The stimulus will be a combination of horizontal visual motion and a head maneuver. The subject will sit in a stationary chair, and a treatment provider will stand behind the subject. While the subject views the slow horizontal motion up to 10°/s of vertical stripes, the provider will gently hold the head of the subject above the ears and tilt the head in the roll (side-to-side) or pitch (up-down) plane by approximately ±20° at the frequency of 0.2 to 0.05 Hz for up to 10 min. The treatment will be repeated with breaks of approximately 5 min. A treatment session will last no longer 120 min including the breaks.
In Groups 1, 3, and 4, subjects will sit in a chair placed in the center of a cylindrical enclosure of a 95 cm radius, and full-field visual motion will be generated with light projected on the wall of this chamber. In Group 2, visual motion will be presented on the screen of a VR headset. Unlike groups 3 and 4, groups 1 and 2 do not receive any complementary treatment.
VOR HabituationBehavioural
The subject will sit in a chair placed in the center of a cylindrical enclosure of a 95 cm radius. Physical motion will be generated by rotating the chair sinusoidally to the left and right, and full-field visual motion will be generated with light projected on the wall of this chamber. Velocity storage will be weakened by inducing a conflict between physical and visual motions. Subjects will be first treated with a stimulus with a peak speed of 5°/s. The stimulus speed will be gradually increased from 5°/s on Day 1 to 40°/s on Day 5. In total, the subjects are expected to undergo 200-280 min of treatment over the five days, broken up into several 10-20 min sessions per day with a 10-min break in between. If signs or symptoms of motion sickness are reported by the subject (nausea, sweating), the session will be immediately paused. Treatment may be continued after a short rest if the discomfort is alleviated or on the following day.
Visual Motion DesensitizationBehavioural
The subject will be situated in darkness and view the movement of a visual pattern presented on a disk, sized 1 m in diameter and placed 1 m away from the subject with its center at the eye level. The disk will be rotated clockwise and counter-clockwise for up to 10 min at a fixed maximal speed within a treatment session but varying across sessions between 5 to 60°/s. Within a single session, the visual stimulus will be first presented with the subject sitting upright in a chair, and then the treatment will be repeated with the subject standing. The disk will be mounted on a vertical sled, so the center of rotation can be kept at the eye level when sitting and standing. A treatment session will be repeated or conducted with an increased visual motion speed up to 60°/s according to the subject's readiness. In total, the subjects are expected to undergo up to 300 min of treatment over the five days, broken up into several sessions per day with a 10-min break in between
Opposing visual motion stimulusBehavioural
The investigators characterize gravitational pull as a misaligned sense of upright in the velocity storage mechanism, and hypothesize that that this misalignment can be corrected with an opposing visual motion stimulus, e.g., backward pulling will be corrected with upward visual motion.
Patients in Group 5 will undergo view visual motion in a physical setting, and those in Group 6 under a VR setting. In total, the subjects are expected to undergo up to 300 min of treatment over the five days, broken up into several sessions of 1-10 min per day with an approximately 5-min break in between.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: VOR readaptation with full-field OKS | Sham comparator | This group to undergo VOR readaptation with full-field OKS. Groups 1 will be treated with stationary OKS (sham). (Group 1, n=50). Receives: Behavioral: VOR Readaptation |
| Group 2: VOR readaptation with VR googles | Sham comparator | This group to undergo VOR readaptation with VR googles. Groups 2 will be treated with stationary OKS (sham). (Group 2, n=50) Receives: Behavioral: VOR Habituation |
| Group 3: Supplemental VOR habituation | Active comparator | This group to undergo VOR readaptation with full-field OKS combined with a habituation protocol. (Group 3, n=30) Receives: Behavioral: VOR Readaptation; Behavioral: VOR Habituation |
| Group 4: Visual desensitization treatment | Active comparator | This group to undergo VOR readaptation with full-field OKS combined with visual desensitization protocol. (Group 4, n=30) Receives: Behavioral: VOR Readaptation; Behavioral: Visual Motion Desensitization |
| Group 5: Treatment of gravitational pull with OKS with full-field setting | Active comparator | This group with phantom sensation dominated by gravity pull. This group will undergo OKS in a full-field (Group 5, n=20) . Receives: Behavioral: Opposing visual motion stimulus |
| Group 6: Treatment of gravitational pull with OKS with VR setting | Active comparator | This group with phantom sensation dominated by gravity pull. This group will undergo OKS in a VR setting (Group 6, n=20). Receives: Behavioral: Opposing visual motion stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective severity of MdDS-related Symptoms Self-score
The levels of subjective severity of MdDS-related symptoms will be reported on an 11-point Likert scale of 0-10, where 0 is no symptoms, and 10 is the most challenging sensation of that symptom that the patient can imagine. Higher score indicates poorer health outcome.
Measured: Baseline and 6 months
Secondary outcomes (10)
Change in Dizziness Handicap Inventory (DHI)
The form contains 25 questions subdivides into 3 groups to determine the physical, emotional, and functional aspects of disability related to MdDS. Total score range 0-100. Sub-scores: physical disability: 0-24; emotional disability: 0-36; functional disability 0-40. Higher score indicates poorer/better health outcome.
Measured: Baseline and 6 months
Change in Visual Vertigo Analogue Scale (VVAS)
The form contains 9 questions scored 0-10 related to VID. Scores are averaged across all questions. Score >3 - low VID; 3-8 - high VID; >8 - extreme VID. Higher score indicates poorer health outcome.
Measured: Baseline and 6 months
Change in Situational Vertigo Questionnaire (SVQ)
The form Contain 19 questions (scored 0-4) to determine sensitivity to physical motion. Individual scores are averaged. Score <1- not sensitive; 1-3 - sensitive to motion; >3 - highly sensitive to motion. Higher score indicates higher sensitivity to motion.
Measured: Baseline and 6 months
Change in Beck Anxiety Inventory (BAI)
The form contains 21 questions related to anxiety. Each question is ranged 0-3. Individual scores are summated. Total score 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety. Higher score indicates poorer health outcome.
Measured: Baseline and 6 months
Postural stability
Static posturography will be obtained with a custom-designed computer program for a Wii board (Nintendo). The displacement of the center of pressure (COP) over a 1 min period will be measured, and the root means square (RMS) of the postural displacement will be computed to compare the postural stability before and after the treatment. The total trajectory length (maximum excursion) of the COP deviation over 20 s will also be computed. Postural stability will be measured with the subject standing with their feet 30 cm apart and eyes either open or closed.
Measured: During 5 days of treatment
Velocity storage time constant
The time constant (Tc) of velocity storage will be determined from the decay profile of the nystagmus's slow phase velocity generated in response to a rotational step velocity of 60°/s in clockwise and counterclockwise directions in darkness. Movements of the right eye will be recorded with video oculography at a rate of 60 frames/s (ISCAN) or binocularly at 250 fr/s (FNND Inc). After 60 s of rotation, the chair will be stopped, and post-rotatory nystagmus will be recorded to 60 s. The total duration of the test is 5 min. The test will be performed before and after daily habituation sessions.
Measured: During 5 days of treatment
Anonymous REDCap survey
Survey contains information on group and whether treatment was effective initially and 6-months after: 1) strongly agree; 2) somewhat agree; 3) cannot determine difference; 4) symptoms slightly worsened; 5) significantly worsened.
Measured: At 6-month follow-up
Change in the State-Trait Anxiety Inventory (STAI)
A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety.
Measured: Baseline and 6 months
Change in The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item, 4-point scale to assess depression and anxiety based on the total score of 7 items each. Each item is scored 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression.
Measured: Baseline and 6 months
Change in The Vestibular Disorders Activities of Daily Living Scale (VADL)
The Vestibular Disorders Activities of Daily Living Scale (VADL) is a 31-item, 10-point scale to assess functional limitation or disability in people with vestibular disorders focused on essential functional skills and important mobility and instrumental skills. Full score from 1-10, with higher score indicating poorer health outcome.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mal de Débarquement SyndromeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Qualified applicants with dominant oscillatory motion sensations will be randomly assigned to Groups 1 (n=50), 2 (n=50), 3 (n=30), or 4 (n=30), and those with dominant gravitational pull sensation will be randomly assigned to groups 5 (n=20) or 6 (n=20).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Brooklyn College of the City University of New York, Ohio University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Sergei Yakushin, Icahn School of Medicine at Mount Sinai
- Investigators
- Sergei Yakushin, PhD, Principal investigator, Ichan Scool of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460520
- Sponsor's protocol ID
- GCO 21-0162
- Other IDs
- R01DC019928
- Status last verified
- Feb 2026
- First submitted
- 13 Jul 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Yakushin SB, Raphan T, Cho C. Treatment of Gravitational Pulling Sensation in Patients With Mal de Debarquement Syndrome (MdDS): A Model-Based Approach. Front Integr Neurosci. 2022 May 23;16:801817. doi: 10.3389/fnint.2022.801817. eCollection 2022.
PubMed 35676926Yakushin SB, Zink R, Clark BC, Liu C. Readaptation Treatment of Mal de Debarquement Syndrome With a Virtual Reality App: A Pilot Study. Front Neurol. 2020 Aug 18;11:814. doi: 10.3389/fneur.2020.00814. eCollection 2020.
PubMed 33013617Dai M, Cohen B, Cho C, Shin S, Yakushin SB. Treatment of the Mal de Debarquement Syndrome: A 1-Year Follow-up. Front Neurol. 2017 May 5;8:175. doi: 10.3389/fneur.2017.00175. eCollection 2017.
PubMed 28529496
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Robust Treatment Options for Mal de Débarquement Syndrome
- ClinicalTrials.gov ID
- NCT05460520
- Acronym / sponsor ID
- GCO 21-0162
- Conditions
- Mal de Débarquement Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- New York University, Brooklyn College of the City University of New York, Ohio University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Jul 2022 (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.
Mal de Débarquement Syndrome (MdDS) is an under-recognized balance disorder, which is manifested by persistent false sensations of oscillatory self-motion (rocking/swaying) and/or pulling in a specific direction (gravitational pull). Patients with MdDS typically experience additional presumably secondary symptoms, such as heightened sensitivity to visual motion (visually induced dizziness, VID), physical motion (motion sickness, MS), and other debilitating physical, cognitive, or affective problems. MdDS was previously considered intractable, and only recently was a breakthrough made in the clinical laboratory with an introduction of a visual-vestibular therapy protocol, yielding a significant long-term improvement of symptoms, including complete remission, in about 50% of patients. However, the approach is limited in several ways. Firstly, there is a practical limitation in implementing the treatment protocol, which requires a specialized set-up for visual stimulation in a dedicated room. This research will address this limitation by testing the utility of virtual reality technology to implement the treatment protocol. Secondly, patients often retain residual symptoms of VID and MS susceptibility, which often act as a trigger for the recurrence of MdDS. This limitation will be addressed by supplementing the original approach with an additional treatment focusing on VID or MS susceptibility. Thirdly, although the original protocol focused on reducing rocking/swaying sensations, gravitational pull often co-occurs with such sensations, and some experience only that motion sensation. This limitation will be addressed by modifying the original protocol. Two hundred patients with MdDS will be recruited for the study. Bias will be controlled by randomized group assignment and the use of placebo treatments. Patients will be treated for 1-2 hours a day for 5 days. Patients will be followed for up to 6 months. The proposed study will facilitate improved outcomes for MdDS by broadening its treatment options.
Detailed description
Objectives This study aims to improve outcomes of MdDS by broadening its treatment options. Specifically, to improve access to the VOR readaptation treatment, the investigators will test the efficacy of VR goggles in generating visual motion to treat MdDS. If proven to be effective, MdDS patients can be treated locally in many vestibular therapy offices, not only for initial treatment but also for remedial or follow-up treatment when symptoms return. To improve long-term outcomes of MdDS, the investigators will evaluate the efficacy of the treatment of a complementary approach combined with VOR readaptation. The investigators hypothesize that an additional intervention that reduces (habituates) the velocity storage capacity will decrease sensitivity to physical movement and improves MdDS symptoms as well as limits symptom recurrence. In addition the investigators hypothesize that desensitization to visual stimuli can reduce visually induced dizziness frequently observed in patients with MdDS. The investigators will verify whether these complementary treatments will provide a better outcome compared to the readaptation treatment by itself. Lastly, to broaden the scope of the VOR readaptation treatment, the study will address the false sensation of gravitational pull commonly reported by patients. The investigators also hypothesize that a visual motion stimulus without cross-axis head motion can reduce this sensation.
Specific Aims Specific Aim 1: Evaluate the efficacy of VR goggles for VOR readaptation. One hundred patients with oscillatory self-motion sensations will be randomly assigned to undergo VOR readaptation with full-field OKS (Group 1, n=50) or VR goggles (Group 2, n=50). Immediate and up to six-month follow-up results will be compared.
Specific Aim 2: Evaluate the efficacy of habituation and visual desensitization combined with VOR readaptation. Sixty patients with oscillatory self-motion sensations will be randomly assigned to undergo VOR readaptation with full-field OKS combined with a habituation (Group 3, n=30) or visual desensitization (Group 4, n=30) protocol. Immediate and up to six-month follow-up results will be compared to those of Group 1.
Specific Aim 3: Treatment of gravitational pull sensation. The investigators estimate that 40 of 200 patients screened for this study will have a phantom sensation dominated by gravity pull, 20 with only that sensation. These patients will be randomly assigned to undergo OKS in a full-field (Group 5, n=20) or VR setting (Group 6, n=20). Immediate and up to six-month follow-up results will be compared.
How Research Will Be Introduced to Participants:
The study will be introduced to potential participants through public announcements such as ClinicalTrials.gov, referrals from clinicians, or direct contact by investigators to individuals who previously requested to be contacted for the opportunity to participate in an MdDS treatment study.
How Participants Will Be Screened:
Informed consent form will be emailed to individuals interested in study participation. Individuals will be contacted by the investigators over the phone and consented for study participation. Consented potential participants will receive intake forms via email with questions regarding the history and symptom characteristics of MdDS, age, sex, and general medical history. Investigators will review the returned intake forms to determine eligibility for study participation based on the inclusion/exclusion criteria described separately and a telephone interview for confirmation and clarification of the candidate's MdDS symptoms. A nystagmography test will then be requested to verify normal inner ear and central vestibular functioning. When candidates do not qualify for the study, screening data will be de-identified, and only those about MdDS symptom presentation, age, sex, and the reason for exclusion will be kept. Intake form and the nystagmography report of the candidates will be securely transferred to NYU for Dr. Catherine Cho to review. Dr. Cho will then conduct a telephone interview with each candidate, and provide PI with confirmation or denial of candidate eligibility, after which the information reviewed by Dr. Cho will be destroyed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Qualified applicants with dominant oscillatory motion sensations will be randomly assigned to Groups 1 (n=50), 2 (n=50), 3 (n=30), or 4 (n=30), and those with dominant gravitational pull sensation will be randomly assigned to groups 5 (n=20) or 6 (n=20).
| Arm | Type | Receives |
|---|---|---|
| Group 1: VOR readaptation with full-field OKS | Sham comparator | Behavioral: VOR ReadaptationThis group to undergo VOR readaptation with full-field OKS. Groups 1 will be treated with stationary OKS (sham). (Group 1, n=50). |
| Group 2: VOR readaptation with VR googles | Sham comparator | Behavioral: VOR HabituationThis group to undergo VOR readaptation with VR googles. Groups 2 will be treated with stationary OKS (sham). (Group 2, n=50) |
| Group 3: Supplemental VOR habituation | Active comparator | Behavioral: VOR Readaptation, Behavioral: VOR HabituationThis group to undergo VOR readaptation with full-field OKS combined with a habituation protocol. (Group 3, n=30) |
| Group 4: Visual desensitization treatment | Active comparator | Behavioral: VOR Readaptation, Behavioral: Visual Motion DesensitizationThis group to undergo VOR readaptation with full-field OKS combined with visual desensitization protocol. (Group 4, n=30) |
| Group 5: Treatment of gravitational pull with OKS with full-field setting | Active comparator | Behavioral: Opposing visual motion stimulusThis group with phantom sensation dominated by gravity pull. This group will undergo OKS in a full-field (Group 5, n=20) . |
| Group 6: Treatment of gravitational pull with OKS with VR setting | Active comparator | Behavioral: Opposing visual motion stimulusThis group with phantom sensation dominated by gravity pull. This group will undergo OKS in a VR setting (Group 6, n=20). |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Conformable diagnosis of Mal de Débarquement Syndrome including significant improvement of symptoms with passive motion.
Key exclusion criteria (6 listed)
- A history of abnormal inner ear or central vestibular function indicated by abnormal nystagmography test (abnormal saccades or pursuit, VOR suppression index <85%, no caloric response, decay time constant of response to rotation less than 10 seconds, spontaneous nystagmus).
- Confounding neurological disorders (e.g., multiple sclerosis, Parkinson's, epilepsy, blindness etc.).
- A history of leg, spine, or other injuries that affect their ability to stand or walk without assisting support.
- High level of anxiety as indicated by State-Trait Anxiety Inventory (≥75) and the Beck Anxiety Inventory (≥55).
- Claustrophobia.
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 |
|---|---|---|
| VOR ReadaptationThe stimulus will be a combination of horizontal visual motion and a head maneuver. The subject will sit in a stationary chair, and a treatment provider will stand behind the subject. While the subject views the slow horizontal motion up to 10°/s of vertical stripes, the provider will gently hold the head of the subject above the ears and tilt the head in the roll (side-to-side) or pitch (up-down) plane by approximately ±20° at the frequency of 0.2 to 0.05 Hz for up to 10 min. The treatment will be repeated with breaks of approximately 5 min. A treatment session will last no longer 120 min including the breaks. In Groups 1, 3, and 4, subjects will sit in a chair placed in the center of a cylindrical enclosure of a 95 cm radius, and full-field visual motion will be generated with light projected on the wall of this chamber. In Group 2, visual motion will be presented on the screen of a VR headset. Unlike groups 3 and 4, groups 1 and 2 do not receive any complementary treatment. | Behavioural | Group 1: VOR readaptation with full-field OKS, Group 3: Supplemental VOR habituation, Group 4: Visual desensitization treatment |
| VOR HabituationThe subject will sit in a chair placed in the center of a cylindrical enclosure of a 95 cm radius. Physical motion will be generated by rotating the chair sinusoidally to the left and right, and full-field visual motion will be generated with light projected on the wall of this chamber. Velocity storage will be weakened by inducing a conflict between physical and visual motions. Subjects will be first treated with a stimulus with a peak speed of 5°/s. The stimulus speed will be gradually increased from 5°/s on Day 1 to 40°/s on Day 5. In total, the subjects are expected to undergo 200-280 min of treatment over the five days, broken up into several 10-20 min sessions per day with a 10-min break in between. If signs or symptoms of motion sickness are reported by the subject (nausea, sweating), the session will be immediately paused. Treatment may be continued after a short rest if the discomfort is alleviated or on the following day. | Behavioural | Group 2: VOR readaptation with VR googles, Group 3: Supplemental VOR habituation |
| Visual Motion DesensitizationThe subject will be situated in darkness and view the movement of a visual pattern presented on a disk, sized 1 m in diameter and placed 1 m away from the subject with its center at the eye level. The disk will be rotated clockwise and counter-clockwise for up to 10 min at a fixed maximal speed within a treatment session but varying across sessions between 5 to 60°/s. Within a single session, the visual stimulus will be first presented with the subject sitting upright in a chair, and then the treatment will be repeated with the subject standing. The disk will be mounted on a vertical sled, so the center of rotation can be kept at the eye level when sitting and standing. A treatment session will be repeated or conducted with an increased visual motion speed up to 60°/s according to the subject's readiness. In total, the subjects are expected to undergo up to 300 min of treatment over the five days, broken up into several sessions per day with a 10-min break in between | Behavioural | Group 4: Visual desensitization treatment |
| Opposing visual motion stimulusThe investigators characterize gravitational pull as a misaligned sense of upright in the velocity storage mechanism, and hypothesize that that this misalignment can be corrected with an opposing visual motion stimulus, e.g., backward pulling will be corrected with upward visual motion. Patients in Group 5 will undergo view visual motion in a physical setting, and those in Group 6 under a VR setting. In total, the subjects are expected to undergo up to 300 min of treatment over the five days, broken up into several sessions of 1-10 min per day with an approximately 5-min break in between. | Behavioural | Group 5: Treatment of gravitational pull with OKS with full-field setting, Group 6: Treatment of gravitational pull with OKS with VR setting |
Primary outcome
Change in Subjective severity of MdDS-related Symptoms Self-score
Time frame: Baseline and 6 months
The levels of subjective severity of MdDS-related symptoms will be reported on an 11-point Likert scale of 0-10, where 0 is no symptoms, and 10 is the most challenging sensation of that symptom that the patient can imagine. Higher score indicates poorer health outcome.
10 secondary outcomes
Change in Dizziness Handicap Inventory (DHI)
Time frame: Baseline and 6 months
Change in Visual Vertigo Analogue Scale (VVAS)
Time frame: Baseline and 6 months
Change in Situational Vertigo Questionnaire (SVQ)
Time frame: Baseline and 6 months
Change in Beck Anxiety Inventory (BAI)
Time frame: Baseline and 6 months
Postural stability
Time frame: During 5 days of treatment
Velocity storage time constant
Time frame: During 5 days of treatment
Anonymous REDCap survey
Time frame: At 6-month follow-up
Change in the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline and 6 months
Change in The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 6 months
Change in The Vestibular Disorders Activities of Daily Living Scale (VADL)
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 35676926Yakushin SB, Raphan T, Cho C. Treatment of Gravitational Pulling Sensation in Patients With Mal de Debarquement Syndrome (MdDS): A Model-Based Approach. Front Integr Neurosci. 2022 May 23;16:801817. doi: 10.3389/fnint.2022.801817. eCollection 2022.
- Background: PubMed 33013617Yakushin SB, Zink R, Clark BC, Liu C. Readaptation Treatment of Mal de Debarquement Syndrome With a Virtual Reality App: A Pilot Study. Front Neurol. 2020 Aug 18;11:814. doi: 10.3389/fneur.2020.00814. eCollection 2020.
- Background: PubMed 28529496Dai M, Cohen B, Cho C, Shin S, Yakushin SB. Treatment of the Mal de Debarquement Syndrome: A 1-Year Follow-up. Front Neurol. 2017 May 5;8:175. doi: 10.3389/fneur.2017.00175. eCollection 2017.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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.
Sergei Yakushin, PhD principal investigator
Ichan Scool of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOR Readaptation, VOR Habituation and Visual Motion Desensitization in people with Mal de Débarquement Syndrome, run by Icahn School of Medicine at Mount Sinai 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergei Yakushin, PhD ((212) 241-9349, sergei.yakushin@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective severity of MdDS-related Symptoms Self-score (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460520, which also lists 3 linked publications.
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 17 Feb 2026.