Using vestibular stimulation to treat pain and fatigue

Vestibular Innovation in Pain: An Open Label Trial

This study is testing whether a new treatment that uses cold water in the ear can help people with pain and fatigue feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06559839 on ClinicalTrials.gov

What this trial studies

The VIP trial evaluates the effectiveness and tolerability of vestibulocortical stimulation (VCS), a non-invasive technique that involves irrigating cold water into the ear canal, to alleviate pain, fatigue, and related symptoms. Participants will complete validated patient-reported outcomes before and after the procedure to assess the treatment's impact. The data collected will inform future randomized controlled trials and help integrate VCS into standard clinical practice.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome, long-COVID, or post-treatment Lyme disease syndrome.

Not a fit: Patients with a history of ear injuries, current ear infections, pregnancy, bipolar disorder, or seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, cost-effective treatment option for patients suffering from chronic pain and fatigue.

How similar studies have performed: While the specific approach of VCS is novel, similar non-invasive neuromodulation techniques have shown promise in treating chronic pain in other studies.

Eligibility criteria

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
* Diagnosis of one of the following:

  * Fibromyalgia (FM), with at least a 4/10 average baseline pain on the numeric rating scale at the time of inclusion.
  * Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
  * Long-COVID
  * Post Treatment Lyme Disease Syndrome (PTLDS)

Exclusion Criteria:

An individual with any of the following criteria will be excluded from participation in this study:

* History of tympanic membrane injury, rupture, or surgery

  * Including tympanostomy, or "ear tubes," and/or cochlear implant.
* Ear infection within the last 3 months, or current ear pain.
* Current pregnancy
* Bipolar Disorder
* History of seizures (including non-epileptiform seizures)
* History of syncope
* Inability to lay supine for 30 minutes
* Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study
* Not fluent in English
* History of or current Meniere's Disease
* History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last three months
* History of hospitalization for severe hypertension
* History of vestibular schwannoma or meningioma resection.

Where this trial is running

New York, New York

• Mount Sinai West — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Michael Kaplan, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Michael Kaplan, MD

Conditions: Pain, Fatigue, Quality of Life