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

NCT04213079 | Completed Results FDA Device

• 2 other identifiers: GCO-19-03481R21DC018390-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Mal de Debarquement Syndrome (MdDS)

Keywords

Mal de Debarquement Syndrome; Motion Sickness; body rocking; body swaying; Habituation of velocity storage

Outcome Measures

Primary Outcomes (1)

• 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.

  During treatment (Day 1), Day 5, and 6 month follow up

Secondary Outcomes (5)

• Visual Vertigo Analogue Scale (VVAS)

  Baseline and 6 month follow up

• Dizziness Handicap Inventory (DHI) Questionnaire

  Baseline and 6 month follow up

• VOR Direct Pathway Gain

  Baseline and Day 5

• VOR Indirect Pathway Time Constant

  Baseline and Day 5

• VOR Indirect Pathway Coupling Gain

  Baseline and Day 5

Study Arms (2)

Vestibulo-ocular reflex (VOR)

EXPERIMENTAL

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

Device: re-adaptation of the vestibulo-ocular reflex

Habituation of velocity storage

EXPERIMENTAL

Participants with motion triggered MdDS

Device: Habituation of velocity storage of the vestibulo-ocular reflex

Interventions

re-adaptation of the vestibulo-ocular reflex DEVICE

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.

Vestibulo-ocular reflex (VOR)

Habituation of velocity storage of the vestibulo-ocular reflex DEVICE

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.

Habituation of velocity storage

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age 18-78.

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Vestibular Testing Center

New York, New York, 10029, United States

Location

Related Publications (15)

• 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.

  PMID: 28529496 BACKGROUND

• 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.

  PMID: 12879171 BACKGROUND

• 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.

  PMID: 19645928 BACKGROUND

• 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.

  PMID: 19692515 BACKGROUND

• 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.

  PMID: 21950996 BACKGROUND

• 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.

  PMID: 29910765 BACKGROUND

• 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.

  PMID: 29305644 BACKGROUND

• 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.

  PMID: 25076935 BACKGROUND

• 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.

  PMID: 30699041 BACKGROUND

• 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.

  PMID: 21287155 BACKGROUND

• 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.

  PMID: 18718351 BACKGROUND

• 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.

  PMID: 29459843 BACKGROUND

• 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.

  PMID: 28861030 BACKGROUND

• 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.

  PMID: 30178612 BACKGROUND

• 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.

  PMID: 18497367 BACKGROUND

Related Links

• Guidelines for patients coming for the treatment. Available treatment announcements

MeSH Terms

Conditions

Mal de debarquement; Motion Sickness; Stereotypic Movement Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Sergei Yakushin
• Organization: Icahn School of Medicine at Mount Sinai

sergei.yakushin@mssm.edu

212-241-9349

Study Officials

• Sergei Yakushin, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurology

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: June 15, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations

US (1)