NCT04213079

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

Completed NA Results posted Last updated 3 January 2024

What this trial tests

NA trial testing re-adaptation of the vestibulo-ocular reflex in Mal de Debarquement Syndrome (MdDS) in 47 participants. Completed in 30 November 2022.

Timeline

15 June 2020

Primary endpoint
30 November 2022

30 November 2022

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	47
Start date	15 June 2020
Primary completion	30 November 2022
Estimated completion	30 November 2022
Sites	1 location across United States

Drugs / interventions tested

• re-adaptation of the vestibulo-ocular reflex
• Habituation of velocity storage of the vestibulo-ocular reflex

Conditions studied

• Mal de Debarquement Syndrome (MdDS) — all drugs for Mal de Debarquement Syndrome (MdDS) →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 78, any sex, with Mal de Debarquement Syndrome (MdDS). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Symptoms Self-report of Overall Severity Primary · During treatment (Day 1), Day 5, and 6 month follow up

The overall severity of MdDS-related symptoms was subjectively reported on a single 11-point scale of 0-10, where the score 0 indicated no symptoms and 10 the most difficult of combined symptoms that the patient subject could imagine. Higher score indicates poorer health outcomes. Among the symptoms to consider were: brain fog, head pressure, fullness of ear, heavy head, headache, nausea, blurry vision, fatigue, sensitivity to fluorescent lights, scrolling of computer screen, sensitivity to smell, sensitivity to noise, walking on trampoline, sensation of gravitational pull up or down. Subjects

Day 1

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	5.2	± 1.9
Habituation of Velocity Storage	5.2	± 1.9

Day 5

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	3.2	± 2.1
Habituation of Velocity Storage	2.1	± 1.7

6 month follow up

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	2.9	± 2.0
Habituation of Velocity Storage	3.4	± 2.2

Visual Vertigo Analogue Scale (VVAS) Secondary · Baseline and 6 month follow up

Visual Vertigo Analogue Scale. There are 9 separate visual analogue scales to rate intensity of visual vertigo provoking situation. Each scale is on a 0-10 cm line. Full scale from 0-10. Higher score represents more dizziness.

Baseline

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	4.8	± 2.0
Habituation of Velocity Storage	4.4	± 2.3

6 month follow up

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	2.5	± 2.1
Habituation of Velocity Storage	2.6	± 2.2

Dizziness Handicap Inventory (DHI) Questionnaire Secondary · Baseline and 6 month follow up

Physical, emotional, and functional disability related to MdDS will be assessed with DHI. DHI is a 25-item self report questionnaire, total score range from 0 to 100, with higher score indicating more perceived disability.

Baseline

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	52.1	± 17.3
Habituation of Velocity Storage	47.2	± 16.1

6 month follow up

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	35.3	± 19.5
Habituation of Velocity Storage	32.1	± 18.6

VOR Direct Pathway Gain Secondary · Baseline and Day 5

The vestibulo-ocular reflex (VOR) is a class of reflex eye movement that counters head movement to stabilize vision. A perfect stabilization occurs when the velocity of the retinal image slip is zero, i.e. when the ratio, or gain, of the eye rotation speed to the head rotation speed is one. The VOR is a fast reflex whose direct pathway consists of a three-neuron arc, but also has parallel, indirect pathways that allow integration of signals from the peripheral vestibular organs with those of other sensory modalities such as vision and proprioception to modulate the eye movement response. The g

Baseline

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	0.53	± 0.13
Habituation of Velocity Storage	0.42	± 0.10

6 month follow up

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	0.45	± 0.14
Habituation of Velocity Storage	0.47	± 0.08

VOR Indirect Pathway Time Constant Secondary · Baseline and Day 5

The velocity storage mechanism is an indirect component of the VOR that facilitates the reflex by storing and releasing signals related to head rotation, for example by prolonging the eye movement response beyond the peripheral vestibular activity during head movement and generating similar eye movement response to rotational cues provided by other sensory modalities. The time constant of this indirect VOR pathway is the rate of charging/discharging in the exponential ideation of its behavior, measured in seconds, estimated from the profile of eye rotation speed during prolonged whole-body rot

Baseline

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	16.6	± 3.9
Habituation of Velocity Storage	15.0	± 4.0

Day 5

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	16.0	± 5.4
Habituation of Velocity Storage	15.6	± 4.5

VOR Indirect Pathway Coupling Gain Secondary · Baseline and Day 5

The gain of the indirect VOR pathway is the term that determines the contribution of velocity storage to the profile of eye rotation speed during prolonged whole-body rotation. The measure is normalized to the head rotation velocity and is thus unitless.

Baseline

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	0.102	± 0.022
Habituation of Velocity Storage	0.093	± 0.030

Day 5

Group	Value	95% CI
Vestibulo-ocular Reflex (VOR)	0.080	± 0.033
Habituation of Velocity Storage	0.099	± 0.027

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.