What side effects are associated with this type of intervention?

The most common treatment for Mal de Débarquement Syndrome (MdDS) is visual-vestibular therapy, which aims to enhance sensory integration and reduce false motion sensations. Known side effects of this therapy can include temporary dizziness, nausea, and headaches, particularly during the initial stages of treatment as the body adjusts to the visual and vestibular stimuli. These side effects are generally mild and tend to diminish as therapy progresses. Virtual reality-based adaptations of this therapy are being studied to improve accessibility and effectiveness, with similar side effects expected.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Mal de Débarquement Syndrome (MdDS) mentioned in the provided context. The current research focuses on a visual-vestibular therapy protocol, which has shown significant long-term improvement in symptoms for about 50% of patients. This therapy aims to enhance sensory integration and reduce false motion sensations, and the study is exploring the use of virtual reality technology to implement this protocol more effectively.

What other types of research exist?

Promising novel alternatives to Virtual Reality Visual-Vestibular Therapy for Mal de Débarquement Syndrome patients include: 1) Augmented Reality (AR) therapy, which can provide similar sensory integration benefits without the need for a dedicated room setup. 2) Multisensory integration training, which focuses on combining visual, auditory, and proprioceptive inputs to recalibrate the brain's perception of motion. 3) Neuromodulation techniques, such as transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS), which can target specific brain areas involved in motion perception and reduce false motion sensations.

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Virtual Reality Therapy for Mal de Débarquement Syndrome

N/A

Recruiting

Led By Sergei Yakushin, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6-month follow-up

Awards & highlights

Summary

This trial uses VR goggles to help patients with Mal de Débarquement Syndrome (MdDS) improve their balance and reduce dizziness. The treatment includes additional exercises to help patients get used to movement and reduce their sensitivity to visual motion. The goal is to provide a more accessible and effective treatment option for MdDS patients. The treatment involves specific head movements while watching visual patterns, leading to improvement in MdDS symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified but could include discomfort from VR use such as dizziness or nausea, especially given the sensitivity of participants to visual motion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Subjective severity of MdDS-related Symptoms Self-score

Secondary study objectives

Anonymous REDCap survey

Change in Beck Anxiety Inventory (BAI)

Change in Dizziness Handicap Inventory (DHI)

+7 more

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Group 3: Supplemental VOR habituationActive Control2 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 treatmentActive Control2 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 settingActive Control1 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 settingActive Control1 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 OKSPlacebo Group1 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 googlesPlacebo Group1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mal de Débarquement Syndrome (MdDS) treatments, such as visual-vestibular therapy, aim to recalibrate the brain's perception of motion by exposing patients to controlled visual and vestibular stimuli. This approach enhances sensory integration and reduces false motion sensations, addressing the root cause of MdDS symptoms. This is crucial for patients as it can significantly reduce or eliminate the debilitating sensations of rocking or swaying, thereby improving their overall quality of life.

Management of symptomatic latent nystagmus.Gaze-induced strabismus.Integrating visual search, eye movement training and reversing prism exposure in the treatment of Balint-Holmes syndrome: a single case report.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

886 Previous Clinical Trials

534,843 Total Patients Enrolled

New York UniversityOTHER

234 Previous Clinical Trials

313,695 Total Patients Enrolled

Brooklyn College of the City University of New YorkOTHER

7 Previous Clinical Trials

84,059 Total Patients Enrolled

Media Library

DevRobust Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05460520 — N/A

Mal de Debarquement Syndrome Research Study Groups: Group 1: VOR readaptation with full-field OKS, Group 2: VOR readaptation with VR googles, Group 3: Supplemental VOR habituation, Group 4: Visual desensitization treatment, Group 5: Treatment of gravitational pull with OKS with full-field setting, Group 6: Treatment of gravitational pull with OKS with VR setting

Mal de Debarquement Syndrome Clinical Trial 2023: DevRobust Treatment Highlights & Side Effects. Trial Name: NCT05460520 — N/A

DevRobust Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05460520 — N/A

~112 spots leftby Jan 2027

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