Recruiting

Vestibulocortical Stimulation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07423377

Conditions

Fibromyalgia

Nociplastic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vestibulocortical Stimulation

Study Details

Brief summary:

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.

Conditions

Fibromyalgia

Nociplastic Pain

Study ID

NCT07423377

Start date

Mar 19, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vestibulocortical Stimulation

Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.

sham comparator: Sham Stimulation

Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.

Interventions

Vestibulocortical Stimulation

VCS is a non-invasive bedside procedure using temperate water, and a plastic syringe (no needles). With the participant laying supine, temperate water is irrigated into the external ear canal at 1-2 cc/second.

Primary outcome measure

  • Change in Pain numeric rating scale (NRS) [ Time Frame: Baseline and 1 week ]

Central Contacts and Locations

Central contacts

Talia Torkian

212-241-1671viptrial@mountsinai.org

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Principal Investigator:

Michael Kaplan

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • pain
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-08.