Status:
COMPLETED
Vestibular Innovation in Pain
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Pain
Fatigue
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe \& cost-effective bedside technique - in treating pain, fatigue \& r...
Detailed Description
VCS is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.
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
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06559839
Start Date
October 1 2024
End Date
March 6 2025
Last Update
July 3 2025
Active Locations (1)
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1
Mount Sinai West
New York, New York, United States, 10019