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Vestibulocortical Stimulation for Fibromyalgia Pain

This study is testing a procedure called Vestibulocortical Stimulation (VCS) for people with fibromyalgia, a common pain disorder. VCS is a non-invasive (no needles) procedure where temperate water is gently put into your ear canal using a plastic syringe while you lie down. Researchers want to see if a single session of VCS can quickly improve pain and quality of life. You may be able to join if you are 18 or older, have a fibromyalgia diagnosis, are fluent in English, and have access to a smartphone or computer to complete surveys. The main goal is to measure changes in your pain level one week after the procedure. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 56 participants. It will compare Vestibulocortical Stimulation (VCS) to a sham procedure.
What's involved
You would receive one session of Vestibulocortical Stimulation (VCS) and complete online surveys before and one week after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be measured at baseline and one week after the procedure.

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NCT07423377

Vestibular Innovation in Pain 2

Recruiting
NAAges 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~56 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Vestibulocortical Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain numeric rating scale (NRS)
Measured over Baseline and 1 week

Conditions

Fibromyalgia
Nociplastic Pain

Explore related trials

Fibromyalgia

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Michael Kaplan, MD · PRINCIPAL_INVESTIGATOR · Mount Sinai Hospital, Icahn School of Medicine

Who to contact

Talia Torkian
[email protected]
212-241-1671
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Age equal to or \>18 years old
Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure.
Owns or has access to a smart phone or computer to complete outcome measures
Fluency in English
Diagnosis of Fibromyalgia (FM)
Diagnosis by American College of Rheumatology 2016 questionnaire
Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion.

Exclusion

History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant.
Right ear infection within the last 3 months, or current right ear pain.
Current pregnancy
Bipolar Disorder
History of seizures (including non-epileptiform seizures)
History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke)
Inability to lay supine for 15 minutes
Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia.
Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study.
History of or current Meniere's Disease
History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months
History of hospitalization for severe hypertension
History of vestibular schwannoma or meningioma resection.
Patients taking opioid therapy (not including tramadol).

What this trial measures

  • Change in Pain numeric rating scale (NRS)Baseline and 1 week

    Change in NRS as compared to baseline. Pain numeric rating scale (NRS), Full score on scale from 0-10 (0 = no pain; 10 = pain as bad as you can imagine). Higher scores indicate more pain.