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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

Study Summary

This trial will test whether virtual reality can help people with MdDS, a disorder that causes false sensations of motion.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,276 Total Patients Enrolled

New York UniversityOTHER

226 Previous Clinical Trials

313,917 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals who are younger than 45 years of age participate in this trial?

"The eligibility requirements for this medical trial specify that patients must be at least 18 years old and no older than 78."

Answered by AI

What is the magnitude of the cohort for this medical experiment?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was published on October 1st 2022, is currently recruiting subjects. 200 patients need to be enrolled from a single medical centre."

Answered by AI

Is this experiment still available for enrollment?

"Affirmative, the information available on clinicaltrials.gov supports that this investigation is currently enrolling patients. This study was initially posted to the website on October 1st 2022 and has since gone through numerous iterations with the latest being dated September 26th 2022. The trial requires 200 people from one location for successful completion."

Answered by AI

Who is eligible to enrol in this research program?

"This medical research is seeking 200 people aged 18 to 78 who have been diagnosed with Mal de Débarquement Syndrome. To qualify, a patient must demonstrate significant improvement of symptoms when exposed to passive motion."

Answered by AI