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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 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)

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,051 Total Patients Enrolled
New York UniversityOTHER
227 Previous Clinical Trials
312,769 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
~129 spots leftby Jan 2027
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