Vestibular Innovation in Pain

Description

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.

Conditions

Pain, Fatigue, Quality of Life

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Vestibular Innovation in Pain: An Open Label Trial

Vestibular Innovation in Pain

Condition
Pain
Intervention / Treatment

-

Contacts and Locations

New York

Mount Sinai West, New York, New York, United States, 10019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Michael Kaplan, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-06