Virtual Reality Therapy for Mal de Débarquement Syndrome

Overseen By Sergei Yakushin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Neurological disorders, Anxiety, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 week

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for Mal de Débarquement Syndrome (MdDS), a condition causing constant rocking or swaying sensations. The trial will test whether virtual reality can improve symptoms that often recur or resist current treatments. Participants will be divided into groups to try various approaches, including the DevRobust Treatment (a virtual reality-based visual-vestibular therapy), visual desensitization, and methods to manage gravitational pull sensations. This study may suit those diagnosed with MdDS who notice symptom improvement when passively in motion, such as riding in a car. As an unphased trial, it offers a unique opportunity to explore innovative treatments for MdDS symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that virtual reality (VR) technology is being tested to help people with Mal de Débarquement Syndrome (MdDS), a condition affecting balance and causing feelings of movement. In earlier studies, VR goggles improved symptoms such as dizziness and balance issues. About half of the participants experienced long-term relief, with some even fully recovering.

Regarding safety, VR treatments have generally been well-received. They use visual motion to help the brain adjust, and previous studies have found no major safety issues. This makes VR a promising and potentially safe option for treating MdDS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for Mal de Débarquement Syndrome because it explores innovative uses of virtual reality (VR) and visual therapies. Unlike standard treatments that primarily focus on medications or vestibular therapy, this study investigates the potential of VR goggles and visual desensitization protocols to re-adapt the vestibulo-ocular reflex (VOR). The unique aspect here is the use of full-field optokinetic stimulation (OKS) and VR settings, which may offer more immersive and targeted therapy options. By examining these cutting-edge techniques, researchers hope to uncover new, effective ways to manage and treat the symptoms of this challenging condition.

What evidence suggests that this trial's treatments could be effective for Mal de Débarquement Syndrome?

Research has shown that a special therapy for Mal de Débarquement Syndrome (MdDS) can help about 50% of patients feel significantly better or even symptom-free. This therapy retrains the brain to better handle balance and motion signals. In this trial, participants will join different groups to test various approaches, including the use of virtual reality (VR) to deliver the therapy. Recent studies have explored VR, and it appears to work as well as traditional methods. VR simplifies the exercises needed for improvement. Early research with VR has shown promise in enhancing balance and reducing dizziness, which are main symptoms of MdDS. ^{1 2 3 4 5}

Who Is on the Research Team?

Sergei Yakushin

Principal Investigator

Ichan Scool of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with Mal de Débarquement Syndrome who feel better when in passive motion. It's not suitable for those with claustrophobia, certain neurological disorders like MS or epilepsy, abnormal inner ear function tests, injuries affecting mobility without support, prior VOR readaptation treatment, or high anxiety levels.

Inclusion Criteria

I feel better when moving, and have been diagnosed with Mal de Débarquement Syndrome.

Exclusion Criteria

Confounding neurological disorders (e.g., multiple sclerosis, Parkinson's, epilepsy, blindness etc.)

A history of abnormal inner ear or central vestibular function indicated by abnormal nystagmography test

Claustrophobia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive VOR readaptation treatment with either full-field OKS or VR goggles for 1-2 hours a day over 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline and 6 months

6 months

2 visits (in-person)

Extension

Participants may receive additional treatment focusing on VID or MS susceptibility if symptoms persist

Variable

What Are the Treatments Tested in This Trial?

Interventions

• DevRobust Treatment

Trial Overview

The study tests visual-vestibular therapy using virtual reality to improve MdDS symptoms. It includes treatments like VOR Habituation and Visual Motion Desensitization. Participants are randomly assigned to groups and may receive placebo treatments as a control measure.

How Is the Trial Designed?

Group I: Group 3: Supplemental VOR habituation Active Control 2 Interventions

This group to undergo VOR readaptation with full-field OKS combined with a habituation protocol. (Group 3, n=30)

Group II: Group 4: Visual desensitization treatment Active Control 2 Interventions

This group to undergo VOR readaptation with full-field OKS combined with visual desensitization protocol. (Group 4, n=30)

Group III: Group 5: Treatment of gravitational pull with OKS with full-field setting Active Control 1 Intervention

This group with phantom sensation dominated by gravity pull. This group will undergo OKS in a full-field (Group 5, n=20) .

Group IV: Group 6: Treatment of gravitational pull with OKS with VR setting Active Control 1 Intervention

This group with phantom sensation dominated by gravity pull. This group will undergo OKS in a VR setting (Group 6, n=20).

Group V: Group 1: VOR readaptation with full-field OKS Placebo Group 1 Intervention

This group to undergo VOR readaptation with full-field OKS. Groups 1 will be treated with stationary OKS (sham). (Group 1, n=50).

Group VI: Group 2: VOR readaptation with VR googles Placebo Group 1 Intervention

This group to undergo VOR readaptation with VR googles. Groups 2 will be treated with stationary OKS (sham). (Group 2, n=50)

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Brooklyn College of the City University of New York

Collaborator

Trials

8

Recruited

84,300+

Ohio University

Collaborator

Trials

73

Recruited

17,800+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The study assessed the effects of a 4-week vestibular rehabilitation (VR) program on postural control in a patient with Mal de debarquement syndrome (MdDS) and found no significant improvement in dizziness or postural stability, suggesting that VR may not be an effective treatment for MdDS.

In contrast, a participant with peripheral vestibular impairment showed clear improvements in postural control and dizziness after the VR program, highlighting the need for tailored treatment approaches for different vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questioning the Impact of Vestibular Rehabilitation in Mal de Debarquement Syndrome. Cedras, AM., Moin-Darbari, K., Foisy, K., et al.[2023]

A randomized controlled trial involving 322 participants aged 50 and older showed that internet-based vestibular rehabilitation (VR) maintained improvement in vestibular symptoms for up to 36 months, demonstrating its long-term efficacy.

While there were no significant differences in symptom reduction between the VR groups and usual care, a substantial portion of the usual care group (38%) opted to switch to VR after 6 months, indicating a preference for the VR approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online vestibular rehabilitation for chronic vestibular syndrome: 36-month follow-up of a randomised controlled trial in general practice. van Vugt, VA., Ngo, HT., van der Wouden, JC., et al.[2023]

In a study of 20 patients with unilateral vestibular hypofunction, virtual reality (VR) vestibular rehabilitation was evaluated and compared to conventional therapy, showing promising results in improving symptoms of vertigo.

Both VR and conventional therapy groups reported significant improvements in their symptoms, indicating that VR may be an effective alternative for vestibular rehabilitation, although specific statistical outcomes were not detailed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. Stankiewicz, T., Gujski, M., Niedzielski, A., et al.[2021]

A 4-week virtual reality-based vestibular rehabilitation therapy (VRT) program significantly improved dizziness and balance in 25 patients with peripheral vestibular hypofunction, as shown by a reduction in Dizziness Handicap Inventory scores from 54.60 to 16.84 (p < 0.001).

The therapy also enhanced sensory organization and stability, with significant improvements in the Sensory Organization Test scores and movement parameters, indicating that VR-based VRT can effectively enhance posture stability and quality of life for patients with PVH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based vestibular rehabilitation in patients with peripheral vestibular hypofunction. Başoğlu, Y., Şerbetçioğlu, MB., Çelik, İ., et al.[2023]

A new treatment for mal de debarquement syndrome (MdDS) using a virtual reality system (CAREN) successfully resolved symptoms in a 39-year-old female patient after just two sessions.

The treatment involved passive head rolling while viewing optokinetic stripes, which adapted the vestibulo-ocular reflex (VOR) and led to a significant improvement in the patient's condition, as indicated by a Global Rating of Change score of +7.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Mal de Debarquement Syndrome in a Computer-Assisted Rehabilitation Environment. Hoppes, CW., Vernon, M., Morrell, RL., et al.[2022]

Virtual reality-assisted therapy (VRAT) significantly improves vestibular symptoms in patients with peripheral vestibular disorders compared to conventional vestibular physical therapy (CVPT), as shown by various measures including the Dizziness Handicap Inventory (DHI).

While VRAT shows promise for enhancing rehabilitation outcomes, particularly for peripheral disorders, the high variability in study results indicates a need for further research with larger sample sizes to better understand its effectiveness across different vestibular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Virtual Reality-Assisted Therapy Offer Additional Benefits to Patients With Vestibular Disorders Compared With Conventional Vestibular Physical Therapy? A Meta-analysis. Chu, HY., Song, N., Zhou, ZR., et al.[2023]

Vestibular rehabilitation is an effective exercise-based program that has been shown to improve various symptoms related to vestibular disorders, including imbalance, dizziness, and anxiety, through a process called central compensation.

Recent advancements in techniques such as balance training, gaze stability training, and the use of virtual reality have enhanced the efficacy of vestibular rehabilitation, making it beneficial even for patients with chronic vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Vestibular Rehabilitation. Sulway, S., Whitney, SL.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05460520

DevRobust Treatment for Mal de Débarquement Syndrome

Objectives This study aims to improve outcomes of MdDS by broadening its treatment options. Specifically, to improve access to the VOR readaptation treatment, ...

2.

mountsinai.org

mountsinai.org/clinical-trials/devrobust-treatment-for-mal-de-d-barquement-syndrome

DevRobust Treatment for Mal de Débarquement Syndrome

... visual-vestibular therapy protocol, yielding a significant long-term improvement of symptoms, including complete remission, in about 50% of patients.

3.

withpower.com

withpower.com/trial/phase-syndrome-8-2022-da373

Virtual Reality Therapy for Mal de Débarquement Syndrome

This trial uses VR goggles to help patients with Mal de Débarquement Syndrome (MdDS) improve their balance and reduce dizziness. The treatment includes ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11579859/

A non-inferiority, randomized, open clinical trial - PMC

Virtual reality application matches the most established treatment for Mal de Debarquement Syndrome: A non-inferiority, randomized, open ...

5.

reporter.nih.gov

reporter.nih.gov/project-details/11097148

Project Details - NIH RePORTER

We recently successfully pilot tested the efficacy of virtual reality (VR) goggles for MdDS treatment with the readaptation approach. In this proposed project, ...