Vestibular Innovation in Pain

NCT ID: NCT06559839

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-06

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 & 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.

Detailed Description

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

Conditions

Pain; Fatigue; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fibromyalgia

Patients in this arm meet ACR 2011 criteria for Fibromyalgia.

Group Type: EXPERIMENTAL

Vestibulocortical Stimulation

Intervention Type: OTHER

50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.

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

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.

Group Type: EXPERIMENTAL

Vestibulocortical Stimulation

Intervention Type: OTHER

50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.

Interventions

Vestibulocortical Stimulation

50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.

Intervention Type: OTHER

Other Intervention Names

VCS

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Michael H Kaplan

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Kaplan, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai West

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-23-00885

Identifier Type: -

Identifier Source: org_study_id