Vestibular Innovation in Pain (VIP)

Mount Sinai Health System

Status: Enrolling

Conditions: Quality of Life; Fatigue; Pain

Treatments: Other: Vestibulocortical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06559839

STUDY-23-00885

Details and patient eligibility

About

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 & related symptoms using validated patient-reported outcomes. Data from this trial will be used to guide optimized treatment protocols in future randomized controlled trials and help inform the implementation of VCS into standard clinical practice.

Full description

VCS is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Fibromyalgia

Experimental group

Description:

Patients in this arm meet ACR 2011 criteria for Fibromyalgia.

Treatment:

Other: Vestibulocortical Stimulation

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Long Covid, Post Treatment Lyme Disease Syndrome

Experimental group

Description:

Participants in this arm meet criteria for at least one of the following diseases: Myalgic-Encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID, or Post Treatment Lyme Disease Syndrome.

Treatment:

Other: Vestibulocortical Stimulation