Vestibular Innovation in Pain
NCT Number: NCT06559839
Acronym: VIP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Fatigue|Quality of Life
Interventions: OTHER: Vestibulocortical Stimulation
Sponsor: Icahn School of Medicine at Mount Sinai
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-06
Locations: Mount Sinai West, New York, New York, 10019, United States

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.

Primary Outcome Measures: 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: 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 min, 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 min, 24 hrs, 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 hrs|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|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 min|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 hrs 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 hrs, 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., 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