CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
re-adaptation of the vestibulo-ocular reflex +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04213079
NCT04213079N/ACompleted

Treatments of Mal de Debarquement Syndrome (MdDS) by Habituation of Velocity Storage

Icahn School of Medicine at Mount Sinai·interventional·Posted Dec 30, 2019·Updated Jan 3, 2024

In Brief

A clinical study evaluating re-adaptation of the vestibulo-ocular reflex and Habituation of velocity storage of the vestibulo-ocular reflex for Mal de Debarquement Syndrome (MdDS). Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 30, 2019
Enrollment StartJun 15, 2020
Primary CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.5 years ago

Interventions

re-adaptation of the vestibulo-ocular reflexdevice

The VOR will be readapted by activating velocity storage with full-field optokinetic motion at 5°/s in a set direction while the head is oscillated with a set frequency and direction. The readaptation training will be conducted in repeated modules, each lasting for 1-5 min. The expected duration of daily sessions varies from 30 to 90 min. A day's session will be terminated if patient no longer feel symptoms of MdDS.

Habituation of velocity storage of the vestibulo-ocular reflexdevice

The central (velocity storage) time constant will be reduced by inducing cancellation of two velocity storage-mediated responses: OKN and the VOR. Sinusoidal rotation at 0.017 Hz (1 revolution/min) in darkness advances the slow phase eye velocity of the VOR by 32º. In contrast, the OKN at this frequency has no phase advancement. Thus, to counteract the VOR by OKN, the optokinetic stimulus should be set to 32º phase advance the out of phased head rotation stimulus. Since the conflict stimulus is expected to be overwhelming to patients at higher chair velocities, subjects will be first trained with a 10°/s stimulus. In a previous study, no complaints were reported when subjects were tested at such low velocities. Preliminary testing show signs of symptom improvement when the peak velocity reached 30°/s to 40°/s.