Vestibulocortical Stimulation for Fibromyalgia: A Quick Bedside Test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Fibromyalgia is treated with limited success and notable side effects, so this study explores a simple, low-cost bedside technique called vestibulocortical stimulation (VCS). Participants receive one VCS session or a sham procedure and report pain and quality of life using validated questionnaires. The trial uses a randomized, sham-controlled design to determine if VCS produces meaningful short-term benefits. Eligible adults must have fibromyalgia, consent, access to a digital device, and English fluency. Safety considerations focus on ear health, with exclusions for recent ear issues, pregnancy, and certain psychiatric or neurological histories.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• Mount Sinai West
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Michael Kaplan, MD — Mount Sinai Hospital, Icahn School of Medicine
• Study coordinator: Talia Torkian
• Email: viptrial@mountsinai.org
• Phone: 212-241-1671

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.