Vestibular Innovation in Pain

NCT06559839 | Completed

• 1 other identifier: STUDY-23-00885
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Diary pain numeric rating scale (Pain NRS) scores

  Change in diary pain scores on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale from 0-10, with higher score indicating worse pain.

  Baseline and at 1 week after VCS

Secondary Outcomes (10)

• Acute and Longitudinal Change in numeric rating scale (Pain NRS)

  Baseline and at 30 minutes, 24 hours, 2 weeks, and 4 weeks

• Percentage of Patients with Numeric Rating Scale (NRS) pain scores > = to 30% and 50%

  30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks

• Brief Pain Inventory- Short Form

  24 hours

• Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

  1 week, 2 weeks, 4 weeks

• Overall Well Being Numeric Rating Scale (NRS)

  at 30 minutes

Study Arms (2)

Fibromyalgia

EXPERIMENTAL

Patients in this arm meet ACR 2011 criteria for Fibromyalgia.

Other: Vestibulocortical Stimulation

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

EXPERIMENTAL

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.

Other: Vestibulocortical Stimulation

Interventions

Vestibulocortical Stimulation OTHER

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

Also known as: VCS

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
• Long-COVID
• Post Treatment Lyme Disease Syndrome (PTLDS)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Pain; Fatigue

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Kaplan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: October 1, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)