Vestibular Innovation in Pain (VIP)

Vestibular Innovation in Pain: An Open Label Trial

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Fatigue
• Intervention / Treatment: Other: Vestibulocortical Stimulation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibromyalgia; Patients in this arm meet ACR 2011 criteria for Fibromyalgia.	Other: Vestibulocortical Stimulation; 50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.; Other Names: VCS
Experimental: 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.	Other: Vestibulocortical Stimulation; 50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.; Other Names: VCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score	Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) measures seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and the ability to participate in social roles and activities. Each domain has 4 questions ranked on a 5-point scale, and refer to the 7 previous days except physical function which has not time frame. Scoring is standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate poorer health outcomes for anxiety, depression, fatigue, ability to participate in social roles and activities, and pain interference domains. Lower scores reflect worse outcomes for physical function and sleep disturbances domains.	1 week, 2 weeks, 4 weeks
Fatigue Severity Scale (FSS) Score	A 9-item scale, each item scored from 1 (strongly disagree) to 7 (strongly agree). Total scale from 9-63, with higher score indicating greater fatigue.	1 weeks, 2 weeks, 4 weeks
Epworth Sleepiness Scale (ESS) Score	The Epworth Sleepiness Scale (ESS) is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.	1 weeks, 2 weeks, 4 weeks
Compass-31 Score	The COMPASS-31 (Composite Autonomic Symptom Score) is a comprehensive questionnaire used to evaluate symptoms of autonomic dysfunction in various body systems. It contains 31 questions across different 7 domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal (mixed upper and diarrhea), constipation, bladder, and pupillomotor function. Single cumulative weighted score designed to reflect global autonomic dysfunction. Score is 0-100, greater than or = to 20 suggests moderate to severe autonomic dysfunction	1 weeks, 2 weeks, 4 weeks
Acute and Longitudinal Change in numeric rating scale (Pain NRS)	Pain scores on an 11 point numeric rating scale at 30 minutes, 2 weeks, and 4 weeks after VCS as compared to baseline. Full scale from 0-10, with higher score indicating worse pain.	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%	Percentage of patients with change in pain assessed by NRS pain scores > equal to 30% and 50%. NRS full scale from 0-10, with higher score indicating worse pain.	30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks
Brief Pain Inventory- Short Form	A 9-item instrument. Question 2 which is a diagram and question 7 which asks about medications, will be excluded. Total score from 0 to 10, with higher score indicating worse outcomes.	24 hours
Overall Well Being Numeric Rating Scale (NRS)	Overall well-being scores on an 11 point numeric rating scale at 30 minutes. NRS full scale from 0-10, with higher score suggesting greater overall wellbeing.	at 30 minutes
VCS Tolerability Survey	A seventeen question tolerability instrument developed specifically for caloric stimulation to assess tolerability by measuring the frequency and intensity of headaches, nausea, and vertigo. The tolerability scale does not have a total score just individual questions re headache nausea vertigo discomfort and grades intensities rated on a 0-10 scale, higher numbers reflecting higher severity of symptoms.	24 hours post VCS
Patient Global Impression of Change (PGIC) Score	The Patient's Global Impression of Change (PGIC) will be used to assess pain. It will evaluate pain from no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7). The patients will answer the following question: "Since beginning treatment at this program, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life related to your condition?". Full score from 0-7, with higher score indicating more improvement.	24 hours, 1 week, 2 week, 4 weeks

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Michael Kaplan, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY-23-00885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No