Vestibulocortical Stimulation for Fibromyalgia

(VIPR Trial)

TT
Overseen ByTalia Torkian
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain \& improving quality of life using validated patient-reported outcomes.

Who Is on the Research Team?

MK

Michael Kaplan, MD

Principal Investigator

Mount Sinai Hospital, Icahn School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

My pain level is between 4 and 9 out of 10 right now.
* Provision of signed and dated informed consent form
I am 18 years old or older.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single session of vestibulocortical stimulation (VCS) or sham stimulation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Multiple assessments at 30 minutes, 24 hours, 1 week, 2 weeks, 3 weeks, and 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vestibular Innovation in Pain 2

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Vestibulocortical StimulationExperimental Treatment1 Intervention
Group II: Sham StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+