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Vestibular Innovation in Pain

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Conditions

PainFatigueQuality of Life

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vestibular Innovation in Pain: An Open Label Trial

Quick Facts

Study Start:2024-10-01
Study Completion:2025-03-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06559839

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Age equal to or \>18 years old
  3. * Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure.
  4. * Owns or has access to a smart phone or computer to complete outcome measures
  5. * Diagnosis of one of the following:
  6. * Fibromyalgia (FM), with at least a 4/10 average baseline pain on the numeric rating scale at the time of inclusion.
  7. * Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
  8. * Long-COVID
  9. * Post Treatment Lyme Disease Syndrome (PTLDS)
  1. * History of tympanic membrane injury, rupture, or surgery
  2. * Including tympanostomy, or "ear tubes," and/or cochlear implant.
  3. * Ear infection within the last 3 months, or current ear pain.
  4. * Current pregnancy
  5. * Bipolar Disorder
  6. * History of seizures (including non-epileptiform seizures)
  7. * History of syncope
  8. * Inability to lay supine for 30 minutes
  9. * Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study
  10. * Not fluent in English
  11. * History of or current Meniere's Disease
  12. * History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last three months
  13. * History of hospitalization for severe hypertension
  14. * History of vestibular schwannoma or meningioma resection.

Contacts and Locations

Principal Investigator

Michael Kaplan, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Michael Kaplan, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2025-03-06

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2025-03-06

Terms related to this study

Additional Relevant MeSH Terms

  • Pain
  • Fatigue
  • Quality of Life