Virtual Reality Therapy for Mal de Débarquement Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Sergei Yakushin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Neurological disorders, Anxiety, Claustrophobia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Virtual Reality Therapy for Mal de Débarquement Syndrome?

A case report showed that using a virtual reality environment to replicate a treatment involving head movements and visual stimuli led to complete symptom resolution in a patient with Mal de Débarquement Syndrome after just two sessions. Additionally, virtual reality-assisted therapy has been shown to improve treatment outcomes for vestibular disorders compared to conventional therapy.

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Is virtual reality therapy safe for treating vestibular conditions?

Virtual reality therapy has been used safely in treating various vestibular conditions, such as peripheral vestibular dysfunction and Mal de Débarquement Syndrome, with no reported adverse effects in the studies reviewed.

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How is the DevRobust Treatment for Mal de Débarquement Syndrome different from other treatments?

The DevRobust Treatment is unique because it uses virtual reality to replicate a specific therapy that involves passive head movements while watching moving stripes, which helps readjust the vestibulo-ocular reflex (VOR) and alleviate symptoms. This approach is novel compared to traditional vestibular rehabilitation, which may not specifically target the maladaptation seen in Mal de Débarquement Syndrome.

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Eligibility Criteria

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

Trial Timeline

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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Icahn School of Medicine at Mount Sinai New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

New York University Collaborator

Brooklyn College of the City University of New York Collaborator

Ohio University Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of Mal de Debarquement Syndrome in a Computer-Assisted Rehabilitation Environment. [2022] Individuals with mal de debarquement syndrome (MdDS) describe symptoms of swaying, rocking, and/or bobbing after sea or air travel. These symptoms may be because of maladaptation of the vestibulo-ocular reflex (VOR) to roll of the head during rotation. Dai and colleagues have developed a treatment paradigm that involves passive roll of the patient's head while watching optokinetic stripes, resulting in adaption of the VOR and improvement of MdDS. The purpose of this case report is to describe replication of this treatment paradigm in a virtual reality environment with successful resolution of symptoms in two visits. A 39-year-old female reported swaying and rocking after returning from a 7-day cruise. The patient was treated with two sessions in a computer-assisted rehabilitation environment (CAREN). The patient canceled her third visit because of complete resolution of her symptoms. Her Global Rating of Change was +7 (on a 15-point scale of -7 to +7). She had returned to her prior level of function. This case report is the first to describe use of the CAREN for effective treatment of MdDS by replicating the treatment paradigm developed by Dai and colleagues.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Questioning the Impact of Vestibular Rehabilitation in Mal de Debarquement Syndrome. [2023] Mal de debarquement syndrome (MdDS) is a rare and poorly understood clinical entity defined as a persistent sensation of rocking and swaying that can severely affect the quality of life. To date, the treatment options are very limited. Even though vestibular rehabilitation (VR) efficacy following peripheral vestibular lesion is well-documented, little is known about its influence on MdDS. The objective of the study was to explore the influence of traditional VR program on postural control in a patient diagnosed with MdDS.

3. England pubmed.ncbi.nlm.nih.gov

Online vestibular rehabilitation for chronic vestibular syndrome: 36-month follow-up of a randomised controlled trial in general practice. [2023] Vestibular rehabilitation (VR) is the preferred treatment for chronic vestibular symptoms such as dizziness and vertigo. An internet-based programme was developed to increase uptake of VR. The authors have previously reported that internet-based VR resulted in a clinically relevant decrease of vestibular symptoms for up to 6 months, compared with usual care.

4. United States 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. [2023] To determine whether virtual reality-assisted therapy (VRAT) significantly improves the treatment of peripheral or central vestibular disorders when compared with conventional vestibular physical therapy (CVPT) alone. Indicators of vestibular symptoms are used to determine this.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Vestibular Rehabilitation. [2019] Vestibular rehabilitation is an exercise-based program that has been in existence for over 70 years. A growing body of evidence supports the use of vestibular rehabilitation in patients with vestibular disorders, and evolving research has led to more efficacious interventions. Through central compensation, vestibular rehabilitation is able to improve symptoms of imbalance, falls, fear of falling, oscillopsia, dizziness, vertigo, motion sensitivity and secondary symptoms such as nausea and anxiety. Early intervention is advised for falls prevention and symptom management; however, symptomatic patients with chronic vestibular disorders may still demonstrate benefit from a course of vestibular rehabilitation. Recent advances in balance and gait training, gaze stability training, habituation training, use of virtual reality, biofeedback, and vestibular prostheses are discussed in this chapter in the context of unilateral and bilateral vestibular disorders.

6. Turkey pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based vestibular rehabilitation in patients with peripheral vestibular hypofunction. [2023] The rehabilitation of classical peripheral vestibular disorders is long and costly. Recently, interactive systems based on virtual reality (VR) technology have reduced the cost of vestibular rehabilitation therapy (VRT) and made the process more enjoyable. This study aims to investigate the effects of VR-based VRT in patients diagnosed with peripheral vestibular hypofunction (PVH).

7. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. [2021] BACKGROUND Vestibular compensation is disrupted in patients with chronic vestibular syndrome. Vestibular rehabilitation is an exercise therapy that optimizes the process of vestibular compensation. This study aimed to evaluate virtual reality (VR) vestibular rehabilitation in 20 patients with vertigo due to peripheral vestibular dysfunction at a single center.Our study aim was to initially assess the impact of using virtual reality technology in vestibular rehabilitation. MATERIAL AND METHODS The subjects were 20 patients with unilateral vestibular hypofunction (UVH), as confirmed by videonystagmography. These were divided into 2 groups: Group 1 underwent vestibular rehabilitation using virtual reality and Group 2 was treated by conventional therapy. A VSS-SF questionnaire and the VAS scale were used to assess the effects and levels of patient satisfaction with therapy. RESULTS Both groups demonstrated significantly (P.