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Behavioural Intervention

Vestibulocortical Stimulation for Pain (VIP Trial)

N/A

Recruiting

Led By Michael Kaplan, MD

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

Age equal to or >18 years old

Be older than 18 years old

Must not have

Inability to lay supine for 30 minutes

History of syncope

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well vestibulocortical stimulation (VCS) works in treating pain, fatigue, and related symptoms. The study will use patient-reported outcomes to collect data on the effectiveness

Who is the study for?

The VIP trial is for individuals experiencing pain, fatigue, and issues with their quality of life. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions related to the study's focus.

What is being tested?

This trial tests vestibulocortical stimulation (VCS), a bedside technique aimed at treating symptoms like pain and fatigue. The goal is to determine VCS's effectiveness and how well patients tolerate it over time.

What are the potential side effects?

While specific side effects are not listed, VCS is described as safe and cost-effective. Any potential side effects will be monitored through patient-reported outcomes during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot lay flat on my back for 30 minutes.

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I have a history of fainting.

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I have a history of or currently have Meniere's Disease.

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I have had ear surgery, including ear tubes or a cochlear implant.

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I have had an ear infection or ear pain recently.

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I have been hospitalized for severe high blood pressure.

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I have a history of seizures.

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I am not fluent in English.

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I haven't had a heart attack, stroke, or heart surgery in the last 3 months.

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I have had surgery to remove a brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks 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 Diary pain numeric rating scale (Pain NRS) scores

Secondary study objectives

Acute and Longitudinal Change in numeric rating scale (Pain NRS)

Brief Pain Inventory- Short Form

Compass-31 Score

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Long Covid, Post Treatment Lyme Disease SyndromeExperimental Treatment1 Intervention

Participants in this arm meet criteria for at least one of the following diseases: Myalgic-Encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID, or Post Treatment Lyme Disease Syndrome.

Group II: FibromyalgiaExperimental Treatment1 Intervention

Patients in this arm meet ACR 2011 criteria for Fibromyalgia.

0 / 11Eligibility criteria met