Group 4: Visual desensitization treatment for Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Syndrome+1 More
VOR Readaptation - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 broadening its treatment options.

Eligible Conditions

  • Syndrome
  • Mal de Débarquement Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: At 6-month follow-up

At 6-month follow-up
Anonymous REDCap survey
Baseline and 6 months
Change in Beck Anxiety Inventory (BAI)
Change in Dizziness Handicap Inventory (DHI)
Change in Situational Vertigo Questionnaire (SVQ)
Change in Subjective severity of MdDS-related Symptoms Self-score
Change in The Hospital Anxiety and Depression Scale (HADS)
Change in The Vestibular Disorders Activities of Daily Living Scale (VADL)
Change in Visual Vertigo Analogue Scale (VVAS)
Change in the State-Trait Anxiety Inventory (STAI)
Day 5
Postural stability
Velocity storage time constant

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Group 4: Visual desensitization treatment
1 of 6
Group 5: Treatment of gravitational pull with OKS with full-field setting
1 of 6
Group 6: Treatment of gravitational pull with OKS with VR setting
1 of 6
Group 3: Supplemental VOR habituation
1 of 6
Group 1: VOR readaptation with full-field OKS
1 of 6
Group 2: VOR readaptation with VR googles
1 of 6
Active Control
Non-Treatment Group

200 Total Participants · 6 Treatment Groups

Primary Treatment: Group 4: Visual desensitization treatment · Has Placebo Group · N/A

Group 4: Visual desensitization treatmentActiveComparator Group · 2 Interventions: VOR Readaptation, Visual Motion Desensitization · Intervention Types: Behavioral, Behavioral
Group 1: VOR readaptation with full-field OKS
Behavioral
ShamComparator Group · 1 Intervention: VOR Readaptation · Intervention Types: Behavioral
Group 5: Treatment of gravitational pull with OKS with full-field setting
Behavioral
ActiveComparator Group · 1 Intervention: Opposing visual motion stimulus · Intervention Types: Behavioral
Group 6: Treatment of gravitational pull with OKS with VR setting
Behavioral
ActiveComparator Group · 1 Intervention: Opposing visual motion stimulus · Intervention Types: Behavioral
Group 2: VOR readaptation with VR googles
Behavioral
ShamComparator Group · 1 Intervention: VOR Habituation · Intervention Types: Behavioral
Group 3: Supplemental VOR habituationActiveComparator Group · 2 Interventions: VOR Readaptation, VOR Habituation · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6-month follow-up
Closest Location: Icahn School of Medicine at Mount Sinai · New York, NY
Photo of icahn school of medicine at mount sinai 1Photo of icahn school of medicine at mount sinai 2Photo of icahn school of medicine at mount sinai 3
1997First Recorded Clinical Trial
15 TrialsResearching Syndrome
529 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
269 Previous Clinical Trials
87,874 Total Patients Enrolled
4 Trials studying Syndrome
182 Patients Enrolled for Syndrome
New York UniversityOTHER
198 Previous Clinical Trials
299,492 Total Patients Enrolled
3 Trials studying Syndrome
1,456 Patients Enrolled for Syndrome
Brooklyn College of the City University of New YorkOTHER
7 Previous Clinical Trials
84,059 Total Patients Enrolled
Ohio UniversityOTHER
62 Previous Clinical Trials
35,900 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
761 Previous Clinical Trials
493,455 Total Patients Enrolled
9 Trials studying Syndrome
968 Patients Enrolled for Syndrome
Sergei Yakushin, PhDPrincipal InvestigatorIchan Scool of Medicine at Mount Sinai
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Syndrome
50 Patients Enrolled for Syndrome

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.