N/A
N=47
Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage
Mal de Debarquement Syndrome (MdDS)
Bottom Line
View on ClinicalTrials.gov: NCT04213079 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Subjective Symptoms Self-report of Overall Severity — 5.2; 5.2; 3.2; 2.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- re-adaptation of the vestibulo-ocular reflex (Device); Habituation of velocity storage of the vestibulo-ocular reflex (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Symptoms Self-report of Overall Severity |
5.2; 5.2; 3.2; 2.1; 2.9; 3.4 | — |
| SECONDARY Visual Vertigo Analogue Scale (VVAS) |
4.8; 4.4; 2.5; 2.6 | — |
| SECONDARY Dizziness Handicap Inventory (DHI) Questionnaire |
52.1; 47.2; 35.3; 32.1 | — |
| SECONDARY VOR Direct Pathway Gain |
0.53; 0.42; 0.45; 0.47 | — |
| SECONDARY VOR Indirect Pathway Time Constant |
16.6; 15.0; 16.0; 15.6 | — |
| SECONDARY VOR Indirect Pathway Coupling Gain |
0.102; 0.093; 0.080; 0.099 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-78.
Exclusion Criteria
- Patient with serious spinal, neck and legs injuries will be excluded, since postural ability is essential for both treatments.
Data sourced from ClinicalTrials.gov (NCT04213079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.