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Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage

Primary Purpose

Mal de Debarquement Syndrome (MdDS)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
re-adaptation of the vestibulo-ocular reflex
Habituation of velocity storage of the vestibulo-ocular reflex
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mal de Debarquement Syndrome (MdDS) focused on measuring Mal de Debarquement Syndrome, Motion Sickness, body rocking, body swaying, Habituation of velocity storage

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Age 18-78.

Exclusion Criteria:

- Patient with serious spinal, neck and legs injuries will be excluded, since postural ability is essential for both treatments.

Sites / Locations

  • Vestibular Testing Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vestibulo-ocular reflex (VOR)

Habituation of velocity storage

Arm Description

Treatment by re-adaptation of the vestibulo-ocular reflex (VOR) for participants with motion triggered MdDS

Participants with motion triggered MdDS

Outcomes

Primary Outcome Measures

Subjective symptoms self-report
The severity of subjective symptoms will be assessed with self-report on a scale 0-10, where 0 is no symptom and 10 is the most difficult sensation of that symptom that patient can imagine. Higher score indicates more symptoms. Among these symptoms are: 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 will be trained to estimate the level of symptoms to minimize inconsistency.
Subjective symptoms self-report
The severity of subjective symptoms will be assessed with self-report on a scale 0-10, where 0 is no symptom and 10 is the most difficult sensation of that symptom that patient can imagine. Higher score indicates more symptoms. Among these symptoms are: 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 will be trained to estimate the level of symptoms to minimize inconsistency.
Subjective symptoms self-report
The severity of subjective symptoms will be assessed with self-report on a scale 0-10, where 0 is no symptom and 10 is the most difficult sensation of that symptom that patient can imagine. Higher score indicates more symptoms. Among these symptoms are: 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 will be trained to estimate the level of symptoms to minimize inconsistency.

Secondary Outcome Measures

Change in Static posturography
Static posturography will be obtained with a specifically designed computer program for a Wii board (Nintendo). The displacement of center of pressure (COP) over a 1 min period will be measured, and the root mean square 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 obtained with the subject standing with the feet 30 cm apart and eyes either open or closed. The sensation of body bobbing will be assessed by asking the patient to move the wrist up/down to imitate the internal sensation of bobbing and measuring the movement frequency with an accelerometer attached to the wrist. Presence of gravitational pull in sideway, forward or backward directions will be objectively measured with static posturography.
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. Higher score represents more dizziness.
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. Higher score represents more dizziness.
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. Higher score represents more dizziness.
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.
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.
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.

Full Information

First Posted
December 23, 2019
Last Updated
January 20, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT04213079
Brief Title
Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage
Official Title
Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mal de Debarquement Syndrome (MdDS)
Keywords
Mal de Debarquement Syndrome, Motion Sickness, body rocking, body swaying, Habituation of velocity storage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibulo-ocular reflex (VOR)
Arm Type
Experimental
Arm Description
Treatment by re-adaptation of the vestibulo-ocular reflex (VOR) for participants with motion triggered MdDS
Arm Title
Habituation of velocity storage
Arm Type
Experimental
Arm Description
Participants with motion triggered MdDS
Intervention Type
Device
Intervention Name(s)
re-adaptation of the vestibulo-ocular reflex
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Habituation of velocity storage of the vestibulo-ocular reflex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective symptoms self-report
Description
The severity of subjective symptoms will be assessed with self-report on a scale 0-10, where 0 is no symptom and 10 is the most difficult sensation of that symptom that patient can imagine. Higher score indicates more symptoms. Among these symptoms are: 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 will be trained to estimate the level of symptoms to minimize inconsistency.
Time Frame
During treatment (Day 1)
Title
Subjective symptoms self-report
Description
The severity of subjective symptoms will be assessed with self-report on a scale 0-10, where 0 is no symptom and 10 is the most difficult sensation of that symptom that patient can imagine. Higher score indicates more symptoms. Among these symptoms are: 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 will be trained to estimate the level of symptoms to minimize inconsistency.
Time Frame
Immediately after the treatment (Day 4)
Title
Subjective symptoms self-report
Description
The severity of subjective symptoms will be assessed with self-report on a scale 0-10, where 0 is no symptom and 10 is the most difficult sensation of that symptom that patient can imagine. Higher score indicates more symptoms. Among these symptoms are: 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 will be trained to estimate the level of symptoms to minimize inconsistency.
Time Frame
6 month follow-up.
Secondary Outcome Measure Information:
Title
Change in Static posturography
Description
Static posturography will be obtained with a specifically designed computer program for a Wii board (Nintendo). The displacement of center of pressure (COP) over a 1 min period will be measured, and the root mean square 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 obtained with the subject standing with the feet 30 cm apart and eyes either open or closed. The sensation of body bobbing will be assessed by asking the patient to move the wrist up/down to imitate the internal sensation of bobbing and measuring the movement frequency with an accelerometer attached to the wrist. Presence of gravitational pull in sideway, forward or backward directions will be objectively measured with static posturography.
Time Frame
Baseline and during the treatment.(Days 1-4)
Title
Visual Vertigo Analogue Scale (VVAS)
Description
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. Higher score represents more dizziness.
Time Frame
Baseline
Title
Visual Vertigo Analogue Scale (VVAS)
Description
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. Higher score represents more dizziness.
Time Frame
Immediately after the treatment (Day 4)
Title
Visual Vertigo Analogue Scale (VVAS)
Description
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. Higher score represents more dizziness.
Time Frame
6 month follow-up.
Title
Dizziness Handicap Inventory (DHI) questionnaire
Description
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.
Time Frame
Baseline
Title
Dizziness Handicap Inventory (DHI) questionnaire
Description
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.
Time Frame
Immediately after the treatment (Day 4)
Title
Dizziness Handicap Inventory (DHI) questionnaire
Description
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.
Time Frame
6 month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Age 18-78. Exclusion Criteria: - Patient with serious spinal, neck and legs injuries will be excluded, since postural ability is essential for both treatments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei Yakushin, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestibular Testing Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
Citations:
PubMed Identifier
28529496
Citation
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.
Results Reference
background
PubMed Identifier
12879171
Citation
Yakushin 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.
Results Reference
background
PubMed Identifier
19645928
Citation
Eron 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.
Results Reference
background
PubMed Identifier
19692515
Citation
Yakushin 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.
Results Reference
background
PubMed Identifier
21950996
Citation
Kolesnikova 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.
Results Reference
background
PubMed Identifier
29910765
Citation
Mucci 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.
Results Reference
background
PubMed Identifier
29305644
Citation
Mucci 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.
Results Reference
background
PubMed Identifier
25076935
Citation
Dai 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.
Results Reference
background
PubMed Identifier
30699041
Citation
Cohen 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.
Results Reference
background
PubMed Identifier
21287155
Citation
Dai 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.
Results Reference
background
PubMed Identifier
18718351
Citation
Cohen 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.
Results Reference
background
PubMed Identifier
29459843
Citation
Cohen 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.
Results Reference
background
PubMed Identifier
28861030
Citation
Yakushin 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.
Results Reference
background
PubMed Identifier
30178612
Citation
Eron 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.
Results Reference
background
PubMed Identifier
18497367
Citation
Eron 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.
Results Reference
background
Links:
URL
http://mdds.nyc/
Description
Guidelines for patients coming for the treatment. Available treatment announcements
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://mdds.nyc/

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Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage

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