An interventional study of Vestibulocortical Stimulation in Pain, Fatigue and Quality of Life, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
VCS is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 39 is below the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of one of the following:
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
Patients in this arm meet ACR 2011 criteria for Fibromyalgia.
Other: Vestibulocortical Stimulation
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.
Also known as: VCS
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.
Time frame: Baseline and at 1 week after VCS
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.
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%
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.
Time frame: 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.
Time frame: 24 hours
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.
Time frame: 1 week, 2 weeks, 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours, 1 week, 2 week, 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.
Time frame: 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.
Time frame: 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
Time frame: 1 weeks, 2 weeks, 4 weeks
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai