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NCT05460520 · ClinicalTrials.gov registry record · NA
DevRobust Treatment for Mal de Débarquement Syndrome
A NA study of Mal de Débarquement Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05460520: Recruiting NA study of Mal de Débarquement Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05460520 is a NA study of Mal de Débarquement Syndrome that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05460520, a NA study of Mal de Débarquement Syndrome, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL VOR Readaptation
- BEHAVIORAL VOR Habituation
- BEHAVIORAL Visual Motion Desensitization
- BEHAVIORAL Opposing visual motion stimulus
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
What NCT05460520 shows while recruiting
NCT05460520 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Mal de Débarquement Syndrome appearing as the primary indexed condition, and to 4 interventions - of which VOR Readaptation is the first listed.
NCT05460520 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05460520 about?
NCT05460520 is a clinical study titled "DevRobust Treatment 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 seco...
What is the current status of trial NCT05460520?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-01-01. Estimated completion is 2027-04-30.
What conditions does trial NCT05460520 study?
This clinical trial studies the following conditions: Mal de Débarquement Syndrome.
What interventions are being tested in trial NCT05460520?
The interventions under investigation include: VOR Readaptation (BEHAVIORAL), VOR Habituation (BEHAVIORAL), Visual Motion Desensitization (BEHAVIORAL), Opposing visual motion stimulus (BEHAVIORAL).
Who is sponsoring clinical trial NCT05460520?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05460520 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05460520's enrollment target sits among peer trials
200 506th of 2000 higher than 1,435 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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