Phase
Condition
Pain
Pain (Pediatric)
Treatment
Vestibulocortical Stimulation
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 patientreported 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 numericrating scale at the time of inclusion.
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Long-COVID
Post Treatment Lyme Disease Syndrome (PTLDS)
Exclusion
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 theopinion 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 bypassgraft (CABG) in the last three months
History of hospitalization for severe hypertension
History of vestibular schwannoma or meningioma resection.
Study Design
Study Description
Connect with a study center
Mount Sinai West
New York, New York 10019
United StatesSite Not Available
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