DevRobust Treatment for Mal de Débarquement Syndrome

NCT05460520 | Recruiting

• 2 other identifiers: GCO 21-0162R01DC019928
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Mal de Débarquement Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (10)

• Change in Dizziness Handicap Inventory (DHI)

  Baseline and 6 months

• Change in Visual Vertigo Analogue Scale (VVAS)

  Baseline and 6 months

• Change in Situational Vertigo Questionnaire (SVQ)

  Baseline and 6 months

• Change in Beck Anxiety Inventory (BAI)

  Baseline and 6 months

• Postural stability

  During 5 days of treatment

Study Arms (6)

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).

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)

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)

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)

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) .

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).

Behavioral: Opposing visual motion stimulus

Interventions

VOR Readaptation BEHAVIORAL

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.

Group 1: VOR readaptation with full-field OKS; Group 3: Supplemental VOR habituation; Group 4: Visual desensitization treatment

VOR Habituation BEHAVIORAL

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.

Group 2: VOR readaptation with VR googles; Group 3: Supplemental VOR habituation

Visual Motion Desensitization BEHAVIORAL

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

Group 4: Visual desensitization treatment

Opposing visual motion stimulus BEHAVIORAL

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.

Group 5: Treatment of gravitational pull with OKS with full-field setting; Group 6: Treatment of gravitational pull with OKS with VR setting

Eligibility Criteria

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

You may qualify if:

• Conformable diagnosis of Mal de Débarquement Syndrome including significant improvement of symptoms with passive motion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• New York University: collaborator
• Brooklyn College of the City University of New York: collaborator
• Ohio University: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 35676926 BACKGROUND

• Yakushin 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.

  PMID: 33013617 BACKGROUND

• 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

Study Officials

• Sergei Yakushin, PhD

  Ichan Scool of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergei Yakushin, PhD

CONTACT

(212) 241-9349; sergei.yakushin@mssm.edu

Jun Maruta, PhD

CONTACT

(212) 241-7068; jun.maruta@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The group assignment will be based on a random drawing of numbers prepared by Dr. Maruta, to the outcome of which he will be blinded. Dr. Cho (NYU) will interview each participant over the phone prior and at the completion of the final 6-month follow-up to independently record symptom severity scores as reported by the participants. Dr. Cho will be blinded to the type of the treatment that the participants received. Dr. Maruta will perform analyses of objective (posture, rotational test, VNG) and subjective (DHI, SVQ, VVAS, HADS, STAI etc.) data obtained during the treatment and at follow-ups. Dr. Maruta will be blinded to the participants' identity and the type of treatment received.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Proposals should be directed to sergei.yakushin@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (tbd).

Locations

US (1)