---
title: Vestibular Innovation in Pain
nct_id: NCT06559839
overall_status: COMPLETED
phase: NA
sponsor: Icahn School of Medicine at Mount Sinai
study_type: INTERVENTIONAL
primary_condition: Pain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06559839.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06559839"
ct_last_update_post_date: 2025-07-03
last_seen_at: "2026-05-12T06:27:47.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Vestibular Innovation in Pain

**Official Title:** Vestibular Innovation in Pain: An Open Label Trial

**NCT ID:** [NCT06559839](https://clinicaltrials.gov/study/NCT06559839)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 39
- **Lead Sponsor:** Icahn School of Medicine at Mount Sinai
- **Conditions:** Pain, Fatigue, Quality of Life
- **Start Date:** 2024-10-01
- **Completion Date:** 2025-03-06
- **CT.gov Last Update:** 2025-07-03

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Fibromyalgia** (EXPERIMENTAL) — Patients in this arm meet ACR 2011 criteria for Fibromyalgia.
- **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.

## 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.

## Primary Outcomes

- **Change in Diary pain numeric rating scale (Pain NRS) scores** _(time frame: Baseline and at 1 week after VCS)_ — 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.

## Secondary Outcomes

- **Acute and Longitudinal Change in numeric rating scale (Pain NRS)** _(time frame: 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%** _(time frame: 30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks)_
- **Brief Pain Inventory- Short Form** _(time frame: 24 hours)_
- **Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score** _(time frame: 1 week, 2 weeks, 4 weeks)_
- **Overall Well Being Numeric Rating Scale (NRS)** _(time frame: at 30 minutes)_
- **VCS Tolerability Survey** _(time frame: 24 hours post VCS)_
- **Patient Global Impression of Change (PGIC) Score** _(time frame: 24 hours, 1 week, 2 week, 4 weeks)_
- **Fatigue Severity Scale (FSS) Score** _(time frame: 1 weeks, 2 weeks, 4 weeks)_
- **Epworth Sleepiness Scale (ESS) Score** _(time frame: 1 weeks, 2 weeks, 4 weeks)_
- **Compass-31 Score** _(time frame: 1 weeks, 2 weeks, 4 weeks)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mount sinai west|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06559839.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06559839*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*