NCT05460520 DevRobust Treatment for Mal de Débarquement Syndrome
| NCT ID | NCT05460520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Mal de Débarquement Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Conformable diagnosis of Mal de Débarquement Syndrome including significant improvement of symptoms with passive motion. Exclusion Criteria: * 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.
Contact & Investigator
Sergei Yakushin, PhD
PRINCIPAL INVESTIGATOR
Ichan Scool of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05460520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 78 Years, studying Mal de Débarquement Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05460520 currently recruiting?
Yes, NCT05460520 is actively recruiting participants. Contact the research team at sergei.yakushin@mssm.edu for enrollment information.
Where is the NCT05460520 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05460520 clinical trial?
NCT05460520 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Sergei Yakushin, PhD at Ichan Scool of Medicine at Mount Sinai. The trial plans to enroll 200 participants.