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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 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. The trial reports 1 study location across 1 state.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05460520
The ClinicalTrials.gov registry entry for NCT05460520 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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