Vagus Nerve Stimulation for Fibromyalgia

N/A

Waitlist Available

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Older than 18 years old

Be older than 18 years old

Must not have

Subjects who have unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease) or who have functional deficits, as self-reported

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to visit 19 (at 4 weeks)

Summary

This trial is testing a new method of pain control for people with fibromyalgia. This method involves using a small device placed on the ear that stimulates a nerve. Previous studies suggest that this method

Who is the study for?

This trial is for individuals with fibromyalgia, a condition characterized by widespread musculoskeletal pain. Participants should be diagnosed with fibromyalgia or myofascial pain syndrome to qualify.

What is being tested?

The study is testing the effects of transauricular vagus nerve stimulation (taVNS), which involves a non-invasive device placed on the ear to potentially alleviate pain in fibromyalgia patients.

What are the potential side effects?

While taVNS is generally considered safe and low-cost, potential side effects may include mild discomfort at the site of stimulation, headache, dizziness, or changes in heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled health issues like diabetes or heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to visit 19 (at 4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to visit 19 (at 4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to visit 19 (at 4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

pain severity using the Brief Pain Inventory (BPI pain)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active taVNSExperimental Treatment1 Intervention

TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hertz (Hz), 200-250 us, and with adjustable intensity for 60 min for 16 sessions.

Group II: Sham taVNSPlacebo Group1 Intervention

Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min for 16 sessions there will be no current and the device will be turned off.

0 / 2Eligibility criteria met