Mal de Debarquement Syndrome (MdDS)NCT04213079
Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage
A study testing re-adaptation of the vestibulo-ocular reflex and Habituation of velocity storage of the vestibulo-ocular reflex in people with Mal de Debarquement Syndrome (MdDS), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Mal de Debarquement Syndrome (MdDS) is an under-recognized but nevertheless common balance disorder, which in most cases occurs after exposure to prolonged passive motion. The current treatment approaches focus on reducing symptoms, but they can be retriggered. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Mal de Debarquement Syndrome (MdDS)
- What is being tested?
- re-adaptation of the vestibulo-ocular reflex and Habituation of velocity storage of the vestibulo-ocular reflex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 30 Nov 2022
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-78.
Who cannot join
- Patient with serious spinal, neck and legs injuries will be excluded, since postural ability is essential for both treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Mal de Debarquement Syndrome (MdDS) is an under-recognized but nevertheless common balance disorder, which in most cases occurs after exposure to prolonged passive motion. The current treatment approaches focus on reducing symptoms, but they can be retriggered. This project aims to shift the focus of MdDS treatment to permanently eliminating the symptom trigger while also minimizing symptoms.
Read the detailed description
Mal de Debarquement Syndrome (MdDS) is an under-recognized but nevertheless common balance disorder, primarily manifested by constant self-motion sensations consisting of rocking/swaying or gravitational pull of the body, which are accompanied by fatigue, migraine, hypersensitivity to light/noise/crowds, visually induced dizziness, and cognitive dysfunctions. As the name implies ("disembarkation sickness"), in most cases MdDS occurs after exposure to prolonged passive motion, specified as motion-triggered (MT) MdDS. However, the symptoms of MdDS can also occur without a motion trigger, termed as spontaneous MdDS. MdDS is debilitating and entails various mental health issues, such as suicidal thoughts, depression, and anxiety. Treatments for this disorder are still limited, as the specific underlying pathophysiology remains unclear. Recently, the team developed the first treatment method that can safely and effectively ease MdDS symptoms in the majority of patients via readaptation of the vestibulo-ocular reflex (VOR). The hypothesis underlying this treatment is that MdDS is caused by maladaptation of the functional component of the VOR called velocity storage, whose readaptation can be stimulated by exposure to whole-field visual motion coupled with head tilts. Over the past several years, more than 500 patients from around the world have been treated with this method. The success rate immediately after this treatment is 75% for MT MdDS, but some patients report return of symptoms after subsequent flights or prolonged car rides. Thus, the effectiveness of the current MdDS treatment protocol can depend on a serious practical limitation of needing to permanently avoid transportation. Building on the previous hypothesis of velocity storage maladaptation, the study team currently hypothesizes that another method, based on the reduction (habituation) of the velocity storage, can also resolve MdDS symptoms. Velocity storage can be greatly habituated within 4-5 days using a protocol previously developed in the study team's laboratory to reduce susceptibility to motion sickness. Preliminary data support the application of this protocol to MdDS. Moreover, since animal-based research suggests that velocity storage habituation is permanently retained, the study team further hypothesizes that this new treatment method yields robust long-term outcomes. In this project, 50 MT MdDS patients with otherwise normal vestibular and neurological functions will be randomly assigned into two groups, one to be treated by velocity storage habituation and the other by readaptation. Patients will be followed up for 6 months. Based on the preliminary data, the study team expects both groups to yield similar initial success rates for symptom improvement. However, the study team expects the group undergoing the habituation protocol to better retain the initial treatment impact in the long term. This project will significantly impact the MdDS treatment practice. The current approach focuses on reducing symptoms, but they can be retriggered by another prolonged exposure to passive motion. The habituation approach on the other hand focuses on permanently minimizing the symptom trigger while also minimizing symptoms. This project will also increase the current understanding of recurrent MdDS.
- Conditions
- Mal de Debarquement Syndrome (MdDS)
- Being tested
- re-adaptation of the vestibulo-ocular reflex, Habituation of velocity storage of the vestibulo-ocular reflex
- Keywords
- Mal de Debarquement Syndrome, Motion Sickness, body rocking, body swaying, Habituation of velocity storage
- Medical subject headings
- Mal de debarquement, Motion Sickness, Stereotypic Movement Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-adaptation of the vestibulo-ocular reflexDevice
The VOR will be readapted by activating velocity storage with full-field optokinetic motion at 5°/s in a set direction while the head is oscillated with a set frequency and direction. The readaptation training will be conducted in repeated modules, each lasting for 1-5 min. The expected duration of daily sessions varies from 30 to 90 min. A day's session will be terminated if patient no longer feel symptoms of MdDS.
Habituation of velocity storage of the vestibulo-ocular reflexDevice
The central (velocity storage) time constant will be reduced by inducing cancellation of two velocity storage-mediated responses: OKN and the VOR. Sinusoidal rotation at 0.017 Hz (1 revolution/min) in darkness advances the slow phase eye velocity of the VOR by 32º. In contrast, the OKN at this frequency has no phase advancement. Thus, to counteract the VOR by OKN, the optokinetic stimulus should be set to 32º phase advance the out of phased head rotation stimulus. Since the conflict stimulus is expected to be overwhelming to patients at higher chair velocities, subjects will be first trained with a 10°/s stimulus. In a previous study, no complaints were reported when subjects were tested at such low velocities. Preliminary testing show signs of symptom improvement when the peak velocity reached 30°/s to 40°/s.
| Study group | Role | What they receive |
|---|---|---|
| Vestibulo-ocular reflex (VOR) | Experimental | Treatment by re-adaptation of the vestibulo-ocular reflex (VOR) for participants with motion triggered MdDS Receives: Device: re-adaptation of the vestibulo-ocular reflex |
| Habituation of velocity storage | Experimental | Participants with motion triggered MdDS Receives: Device: Habituation of velocity storage of the vestibulo-ocular reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Symptoms Self-report of Overall Severity
The overall severity of MdDS-related symptoms was subjectively reported on a single 11-point scale of 0-10, where the score 0 indicated no symptoms and 10 the most difficult of combined symptoms that the patient subject could imagine. Higher score indicates poorer health outcomes. Among the symptoms to consider were: brain fog, head pressure, fullness of ear, heavy head, headache, nausea, blurry vision, fatigue, sensitivity to fluorescent lights, scrolling of computer screen, sensitivity to smell, sensitivity to noise, walking on trampoline, sensation of gravitational pull up or down. Subjects were trained to estimate the level of symptoms to minimize inconsistency.
Measured: During treatment (Day 1), Day 5, and 6 month follow up
Secondary outcomes (5)
Visual Vertigo Analogue Scale (VVAS)
Visual Vertigo Analogue Scale. There are 9 separate visual analogue scales to rate intensity of visual vertigo provoking situation. Each scale is on a 0-10 cm line. Full scale from 0-10. Higher score represents more dizziness.
Measured: Baseline and 6 month follow up
Dizziness Handicap Inventory (DHI) Questionnaire
Physical, emotional, and functional disability related to MdDS will be assessed with DHI. DHI is a 25-item self report questionnaire, total score range from 0 to 100, with higher score indicating more perceived disability.
Measured: Baseline and 6 month follow up
VOR Direct Pathway Gain
The vestibulo-ocular reflex (VOR) is a class of reflex eye movement that counters head movement to stabilize vision. A perfect stabilization occurs when the velocity of the retinal image slip is zero, i.e. when the ratio, or gain, of the eye rotation speed to the head rotation speed is one. The VOR is a fast reflex whose direct pathway consists of a three-neuron arc, but also has parallel, indirect pathways that allow integration of signals from the peripheral vestibular organs with those of other sensory modalities such as vision and proprioception to modulate the eye movement response. The gain of the direct VOR pathway is the ratio of the eye rotation speed to the head rotation speed at the onset of head rotation, and is a unitless measure.
Measured: Baseline and Day 5
VOR Indirect Pathway Time Constant
The velocity storage mechanism is an indirect component of the VOR that facilitates the reflex by storing and releasing signals related to head rotation, for example by prolonging the eye movement response beyond the peripheral vestibular activity during head movement and generating similar eye movement response to rotational cues provided by other sensory modalities. The time constant of this indirect VOR pathway is the rate of charging/discharging in the exponential ideation of its behavior, measured in seconds, estimated from the profile of eye rotation speed during prolonged whole-body rotation that is the combination of the contributions from the direct and indirect pathways.
Measured: Baseline and Day 5
VOR Indirect Pathway Coupling Gain
The gain of the indirect VOR pathway is the term that determines the contribution of velocity storage to the profile of eye rotation speed during prolonged whole-body rotation. The measure is normalized to the head rotation velocity and is thus unitless.
Measured: Baseline and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 Jun 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
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.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Mal de Debarquement Syndrome (MdDS)Studies 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
- Parallel groups
- Model description
- In this project, 50 motion triggered MdDS patients with otherwise normal vestibular and neurological functions will be randomly assigned into two groups, one to be treated by velocity storage habituation and the other by readaptation. Patients will be followed up for 6 months. Based on the preliminary data, we expect both groups to yield similar initial success rates for symptom improvement.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213079
- Sponsor's protocol ID
- GCO-19-0348
- Other IDs
- 1R21DC018390-01
- Status last verified
- Dec 2023
- First submitted
- 23 Dec 2019
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Dai 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 28529496Yakushin SB, Palla A, Haslwanter T, Bockisch CJ, Straumann D. Dependence of adaptation of the human vertical angular vestibulo-ocular reflex on gravity. Exp Brain Res. 2003 Sep;152(1):137-42. doi: 10.1007/s00221-003-1543-0. Epub 2003 Jul 17.
PubMed 12879171Eron JN, Cohen B, Raphan T, Yakushin SB. Adaptation of orientation of central otolith-only neurons. Ann N Y Acad Sci. 2009 May;1164:367-71. doi: 10.1111/j.1749-6632.2009.03848.x.
PubMed 19645928Yakushin SB, Xiang Y, Cohen B, Raphan T. Dependence of the roll angular vestibuloocular reflex (aVOR) on gravity. J Neurophysiol. 2009 Nov;102(5):2616-26. doi: 10.1152/jn.00245.2009. Epub 2009 Aug 19.
PubMed 19692515Kolesnikova OV, Raphan T, Cohen B, Yakushin SB. Orientation adaptation of eye movement-related vestibular neurons due to prolonged head tilt. Ann N Y Acad Sci. 2011 Sep;1233:214-8. doi: 10.1111/j.1749-6632.2011.06176.x.
PubMed 21950996Mucci V, Canceri JM, Brown R, Dai M, Yakushin SB, Watson S, Van Ombergen A, Jacquemyn Y, Fahey P, Van de Heyning PH, Wuyts F, Browne CJ. Mal de Debarquement Syndrome: A Retrospective Online Questionnaire on the Influences of Gonadal Hormones in Relation to Onset and Symptom Fluctuation. Front Neurol. 2018 May 24;9:362. doi: 10.3389/fneur.2018.00362. eCollection 2018.
PubMed 29910765Mucci V, Canceri JM, Brown R, Dai M, Yakushin S, Watson S, Van Ombergen A, Topsakal V, Van de Heyning PH, Wuyts FL, Browne CJ. Mal de Debarquement Syndrome: a survey on subtypes, misdiagnoses, onset and associated psychological features. J Neurol. 2018 Mar;265(3):486-499. doi: 10.1007/s00415-017-8725-3. Epub 2018 Jan 5.
PubMed 29305644Dai M, Cohen B, Smouha E, Cho C. Readaptation of the vestibulo-ocular reflex relieves the mal de debarquement syndrome. Front Neurol. 2014 Jul 15;5:124. doi: 10.3389/fneur.2014.00124. eCollection 2014.
PubMed 25076935Cohen B, Dai M, Yakushin SB, Cho C. The neural basis of motion sickness. J Neurophysiol. 2019 Mar 1;121(3):973-982. doi: 10.1152/jn.00674.2018. Epub 2019 Jan 30.
PubMed 30699041Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2.
PubMed 21287155Cohen B, Dai M, Yakushin SB, Raphan T. Baclofen, motion sickness susceptibility and the neural basis for velocity storage. Prog Brain Res. 2008;171:543-53. doi: 10.1016/S0079-6123(08)00677-8.
PubMed 18718351Cohen B, Yakushin SB, Cho C. Hypothesis: The Vestibular and Cerebellar Basis of the Mal de Debarquement Syndrome. Front Neurol. 2018 Feb 5;9:28. doi: 10.3389/fneur.2018.00028. eCollection 2018.
PubMed 29459843Yakushin SB, Raphan T, Cohen B. Coding of Velocity Storage in the Vestibular Nuclei. Front Neurol. 2017 Aug 16;8:386. doi: 10.3389/fneur.2017.00386. eCollection 2017.
PubMed 28861030Eron JN, Ogorodnikov D, Horn AKE, Yakushin SB. Adaptation of spatio-temporal convergent properties in central vestibular neurons in monkeys. Physiol Rep. 2018 Sep;6(17):e13750. doi: 10.14814/phy2.13750.
PubMed 30178612Eron JN, Cohen B, Raphan T, Yakushin SB. Adaptation of orientation vectors of otolith-related central vestibular neurons to gravity. J Neurophysiol. 2008 Sep;100(3):1686-90. doi: 10.1152/jn.90289.2008. Epub 2008 May 21.
PubMed 18497367
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage
- ClinicalTrials.gov ID
- NCT04213079
- Acronym / sponsor ID
- GCO-19-0348
- Conditions
- Mal de Debarquement Syndrome (MdDS)
- Keywords
- Mal de Debarquement Syndrome, Motion Sickness, body rocking, body swaying, Habituation of velocity storage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Posted 3 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mal de Debarquement Syndrome (MdDS) is an under-recognized but nevertheless common balance disorder, which in most cases occurs after exposure to prolonged passive motion. The current treatment approaches focus on reducing symptoms, but they can be retriggered. This project aims to shift the focus of MdDS treatment to permanently eliminating the symptom trigger while also minimizing symptoms.
Detailed description
Mal de Debarquement Syndrome (MdDS) is an under-recognized but nevertheless common balance disorder, primarily manifested by constant self-motion sensations consisting of rocking/swaying or gravitational pull of the body, which are accompanied by fatigue, migraine, hypersensitivity to light/noise/crowds, visually induced dizziness, and cognitive dysfunctions. As the name implies ("disembarkation sickness"), in most cases MdDS occurs after exposure to prolonged passive motion, specified as motion-triggered (MT) MdDS. However, the symptoms of MdDS can also occur without a motion trigger, termed as spontaneous MdDS. MdDS is debilitating and entails various mental health issues, such as suicidal thoughts, depression, and anxiety. Treatments for this disorder are still limited, as the specific underlying pathophysiology remains unclear. Recently, the team developed the first treatment method that can safely and effectively ease MdDS symptoms in the majority of patients via readaptation of the vestibulo-ocular reflex (VOR). The hypothesis underlying this treatment is that MdDS is caused by maladaptation of the functional component of the VOR called velocity storage, whose readaptation can be stimulated by exposure to whole-field visual motion coupled with head tilts. Over the past several years, more than 500 patients from around the world have been treated with this method. The success rate immediately after this treatment is 75% for MT MdDS, but some patients report return of symptoms after subsequent flights or prolonged car rides. Thus, the effectiveness of the current MdDS treatment protocol can depend on a serious practical limitation of needing to permanently avoid transportation. Building on the previous hypothesis of velocity storage maladaptation, the study team currently hypothesizes that another method, based on the reduction (habituation) of the velocity storage, can also resolve MdDS symptoms. Velocity storage can be greatly habituated within 4-5 days using a protocol previously developed in the study team's laboratory to reduce susceptibility to motion sickness. Preliminary data support the application of this protocol to MdDS. Moreover, since animal-based research suggests that velocity storage habituation is permanently retained, the study team further hypothesizes that this new treatment method yields robust long-term outcomes. In this project, 50 MT MdDS patients with otherwise normal vestibular and neurological functions will be randomly assigned into two groups, one to be treated by velocity storage habituation and the other by readaptation. Patients will be followed up for 6 months. Based on the preliminary data, the study team expects both groups to yield similar initial success rates for symptom improvement. However, the study team expects the group undergoing the habituation protocol to better retain the initial treatment impact in the long term. This project will significantly impact the MdDS treatment practice. The current approach focuses on reducing symptoms, but they can be retriggered by another prolonged exposure to passive motion. The habituation approach on the other hand focuses on permanently minimizing the symptom trigger while also minimizing symptoms. This project will also increase the current understanding of recurrent MdDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this project, 50 motion triggered MdDS patients with otherwise normal vestibular and neurological functions will be randomly assigned into two groups, one to be treated by velocity storage habituation and the other by readaptation. Patients will be followed up for 6 months. Based on the preliminary data, we expect both groups to yield similar initial success rates for symptom improvement.
| Arm | Type | Receives |
|---|---|---|
| Vestibulo-ocular reflex (VOR) | Experimental | Device: re-adaptation of the vestibulo-ocular reflexTreatment by re-adaptation of the vestibulo-ocular reflex (VOR) for participants with motion triggered MdDS |
| Habituation of velocity storage | Experimental | Device: Habituation of velocity storage of the vestibulo-ocular reflexParticipants with motion triggered MdDS |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-78.
Key exclusion criteria (1 listed)
- Patient with serious spinal, neck and legs injuries will be excluded, since postural ability is essential for both treatments.
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 |
|---|---|---|
| re-adaptation of the vestibulo-ocular reflexThe VOR will be readapted by activating velocity storage with full-field optokinetic motion at 5°/s in a set direction while the head is oscillated with a set frequency and direction. The readaptation training will be conducted in repeated modules, each lasting for 1-5 min. The expected duration of daily sessions varies from 30 to 90 min. A day's session will be terminated if patient no longer feel symptoms of MdDS. | Device | Vestibulo-ocular reflex (VOR) |
| Habituation of velocity storage of the vestibulo-ocular reflexThe central (velocity storage) time constant will be reduced by inducing cancellation of two velocity storage-mediated responses: OKN and the VOR. Sinusoidal rotation at 0.017 Hz (1 revolution/min) in darkness advances the slow phase eye velocity of the VOR by 32º. In contrast, the OKN at this frequency has no phase advancement. Thus, to counteract the VOR by OKN, the optokinetic stimulus should be set to 32º phase advance the out of phased head rotation stimulus. Since the conflict stimulus is expected to be overwhelming to patients at higher chair velocities, subjects will be first trained with a 10°/s stimulus. In a previous study, no complaints were reported when subjects were tested at such low velocities. Preliminary testing show signs of symptom improvement when the peak velocity reached 30°/s to 40°/s. | Device | Habituation of velocity storage |
Primary outcome
Subjective Symptoms Self-report of Overall Severity
Time frame: During treatment (Day 1), Day 5, and 6 month follow up
The overall severity of MdDS-related symptoms was subjectively reported on a single 11-point scale of 0-10, where the score 0 indicated no symptoms and 10 the most difficult of combined symptoms that the patient subject could imagine. Higher score indicates poorer health outcomes. Among the symptoms to consider were: brain fog, head pressure, fullness of ear, heavy head, headache, nausea, blurry vision, fatigue, sensitivity to fluorescent lights, scrolling of computer screen, sensitivity to smell, sensitivity to noise, walking on trampoline, sensation of gravitational pull up or down. Subjects were trained to estimate the level of symptoms to minimize inconsistency.
5 secondary outcomes
Visual Vertigo Analogue Scale (VVAS)
Time frame: Baseline and 6 month follow up
Dizziness Handicap Inventory (DHI) Questionnaire
Time frame: Baseline and 6 month follow up
VOR Direct Pathway Gain
Time frame: Baseline and Day 5
VOR Indirect Pathway Time Constant
Time frame: Baseline and Day 5
VOR Indirect Pathway Coupling Gain
Time frame: Baseline and Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Background: PubMed 12879171Yakushin SB, Palla A, Haslwanter T, Bockisch CJ, Straumann D. Dependence of adaptation of the human vertical angular vestibulo-ocular reflex on gravity. Exp Brain Res. 2003 Sep;152(1):137-42. doi: 10.1007/s00221-003-1543-0. Epub 2003 Jul 17.
- Background: PubMed 19645928Eron JN, Cohen B, Raphan T, Yakushin SB. Adaptation of orientation of central otolith-only neurons. Ann N Y Acad Sci. 2009 May;1164:367-71. doi: 10.1111/j.1749-6632.2009.03848.x.
- Background: PubMed 19692515Yakushin SB, Xiang Y, Cohen B, Raphan T. Dependence of the roll angular vestibuloocular reflex (aVOR) on gravity. J Neurophysiol. 2009 Nov;102(5):2616-26. doi: 10.1152/jn.00245.2009. Epub 2009 Aug 19.
- Background: PubMed 21950996Kolesnikova OV, Raphan T, Cohen B, Yakushin SB. Orientation adaptation of eye movement-related vestibular neurons due to prolonged head tilt. Ann N Y Acad Sci. 2011 Sep;1233:214-8. doi: 10.1111/j.1749-6632.2011.06176.x.
- Background: PubMed 29910765Mucci V, Canceri JM, Brown R, Dai M, Yakushin SB, Watson S, Van Ombergen A, Jacquemyn Y, Fahey P, Van de Heyning PH, Wuyts F, Browne CJ. Mal de Debarquement Syndrome: A Retrospective Online Questionnaire on the Influences of Gonadal Hormones in Relation to Onset and Symptom Fluctuation. Front Neurol. 2018 May 24;9:362. doi: 10.3389/fneur.2018.00362. eCollection 2018.
- Background: PubMed 29305644Mucci V, Canceri JM, Brown R, Dai M, Yakushin S, Watson S, Van Ombergen A, Topsakal V, Van de Heyning PH, Wuyts FL, Browne CJ. Mal de Debarquement Syndrome: a survey on subtypes, misdiagnoses, onset and associated psychological features. J Neurol. 2018 Mar;265(3):486-499. doi: 10.1007/s00415-017-8725-3. Epub 2018 Jan 5.
- Background: PubMed 25076935Dai M, Cohen B, Smouha E, Cho C. Readaptation of the vestibulo-ocular reflex relieves the mal de debarquement syndrome. Front Neurol. 2014 Jul 15;5:124. doi: 10.3389/fneur.2014.00124. eCollection 2014.
- Background: PubMed 30699041Cohen B, Dai M, Yakushin SB, Cho C. The neural basis of motion sickness. J Neurophysiol. 2019 Mar 1;121(3):973-982. doi: 10.1152/jn.00674.2018. Epub 2019 Jan 30.
- Background: PubMed 21287155Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2.
- Background: PubMed 18718351Cohen B, Dai M, Yakushin SB, Raphan T. Baclofen, motion sickness susceptibility and the neural basis for velocity storage. Prog Brain Res. 2008;171:543-53. doi: 10.1016/S0079-6123(08)00677-8.
- Background: PubMed 29459843Cohen B, Yakushin SB, Cho C. Hypothesis: The Vestibular and Cerebellar Basis of the Mal de Debarquement Syndrome. Front Neurol. 2018 Feb 5;9:28. doi: 10.3389/fneur.2018.00028. eCollection 2018.
- Guidelines for patients coming for the treatment. Available treatment announcementsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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.
Sergei Yakushin, PhD principal investigator
Icahn School 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 re-adaptation of the vestibulo-ocular reflex and Habituation of velocity storage of the vestibulo-ocular reflex in people with Mal de Debarquement Syndrome (MdDS), 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 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: finished, as of the sponsor's last update on 3 Jan 2024. 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 3 Jan 2024). 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?
Subjective Symptoms Self-report of Overall Severity (time frame: During treatment (Day 1), Day 5, and 6 month follow up). 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 NCT04213079, which also lists 15 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 3 Jan 2024.