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Device

Active taVNS 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am older than 18 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 1Eligibility criteria met

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Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

10,903 Total Patients Enrolled

5 Trials studying Fibromyalgia

336 Patients Enrolled for Fibromyalgia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants for this research study?

"Per the information provided on clinicaltrials.gov, this particular study is not actively seeking participants at present. It was originally posted for recruitment purposes on May 1st, 2024 and last updated on December 21st, 2023. However, it's worth noting that there are currently a total of 98 other trials actively searching for eligible individuals to participate in their respective studies."

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