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Cranial Electrical Stimulation Device

CES with Alpha-stim for Fibromyalgia

N/A

Waitlist Available

Led By Anna Woodbury, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Subjects must self-report consistent, daily pain (greater than 5 on the VAS) >90 days.

Subjects must have intact skin free of infection at the site of electrode placement.

Must not have

Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain.

Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week, and 12 weeks following treatment

Summary

This trial is investigating whether CES is an effective treatment for fibromyalgia and trying to understand how it works so that it can be improved.

Who is the study for?

This trial is for male and female Veterans aged 20-60 with fibromyalgia, diagnosed by a clinician. Participants must have daily pain for over 90 days, intact skin at the electrode site, be right-handed, and willing to consent. Pregnant individuals or those with electrical implants, seizure history, severe psychiatric conditions, certain skin diseases or inability to remain still in an MRI scanner are excluded.

What is being tested?

The study tests Cranial Electrical Stimulation (CES), a non-drug therapy approved by the FDA for pain management. It's being evaluated as an alternative to opioids for treating chronic fibromyalgia pain among Veterans. The trial aims to understand CES's effects on brain function and its potential benefits in pain reduction.

What are the potential side effects?

While not explicitly stated in the provided information, common side effects of CES may include headache, dizziness or lightheadedness; however these tend to be mild and transient. Since it's non-pharmacologic treatment there are typically fewer side effects compared to medication.

Eligibility Criteria

Inclusion Criteria

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

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I have had daily pain above 5 on the pain scale for more than 90 days.

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My skin is healthy and infection-free where the electrode will be placed.

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I am a Veteran aged 20-60 diagnosed with fibromyalgia.

Exclusion Criteria

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

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I have never had seizures or brain structure-altering conditions.

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I do not have psoriasis or skin conditions that could risk infection at the surgery site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week, and 12 weeks following treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week, and 12 weeks following treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, and 12 weeks following treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical Pain Change

Secondary study objectives

Bicep-curl

Handgrip strength

PROMIS Change

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: True CESExperimental Treatment1 Intervention

Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to cranial electrical stimulation (CES), which involves transfer of current from the alpha-stim device using earclip electrodes. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. The treatments can be self administered by the participants. The rs-fcMRI evaluation of neural changes and assessment of clinical pain, function, and quality of life will be performed at the beginning and end of the study.

Group II: Sham CESPlacebo Group1 Intervention

Veterans with fibromyalgia who meet study criteria and are randomized to the sham comparator group will receive standard therapy in addition to a CES device that does not deliver active electrical stimulation. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. The rs-fcMRI evaluation of neural changes and assessment of clinical pain, function, and quality of life will be performed at the beginning and end of the study.

0 / 5Eligibility criteria met