Clinical trial NCT06559839: Vestibular Innovation in Pain
Official title: Vestibular Innovation in Pain: An Open Label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Fatigue
Quality of Life
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change in Diary pain numeric rating scale (Pain NRS) scores
timeFrame: Baseline and at 1 week after VCS
Secondary outcomes:
measure: Acute and Longitudinal Change in numeric rating scale (Pain NRS)
timeFrame: Baseline and at 30 minutes, 24 hours, 2 weeks, and 4 weeks
measure: Percentage of Patients with Numeric Rating Scale (NRS) pain scores > = to 30% and 50%
timeFrame: 30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks
measure: Brief Pain Inventory- Short Form
timeFrame: 24 hours
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Overall Well Being Numeric Rating Scale (NRS)
timeFrame: at 30 minutes
measure: VCS Tolerability Survey
timeFrame: 24 hours post VCS
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: 24 hours, 1 week, 2 week, 4 weeks
measure: Fatigue Severity Scale (FSS) Score
timeFrame: 1 weeks, 2 weeks, 4 weeks
measure: Epworth Sleepiness Scale (ESS) Score
timeFrame: 1 weeks, 2 weeks, 4 weeks
measure: Compass-31 Score
timeFrame: 1 weeks, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Michael Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References: