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NCT05004194 · ClinicalTrials.gov registry record · NA

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT05004194 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 21 participants.

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The verdict

NCT05004194, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study Summary

The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics. The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.

Interventions

  • PROCEDURE Vestibular Caloric Stimulation

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2021-03-19
Est. Completion 2021-07-02
Phase NA

What the Registry Record Tells You About NCT05004194

The ClinicalTrials.gov registry entry for NCT05004194 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Vestibular Caloric Stimulation is the first listed.

NCT05004194 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05004194 about?

NCT05004194 is a clinical study titled "Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia". The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consul...

What is the current status of trial NCT05004194?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2021-03-19. Estimated completion is 2021-07-02.

What interventions are being tested in trial NCT05004194?

The interventions under investigation include: Vestibular Caloric Stimulation (PROCEDURE).

Who is sponsoring clinical trial NCT05004194?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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