CES with Alpha-stim for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Overseen byAnna Woodbury, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a difficult to treat chronic pain condition that is often treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans returning from the gulf war and is already a significant burden in senior Veterans who may have suffered with chronic pain for decades already. Many treatment options for fibromyalgia carry intolerable side effects. CES (Cranial Electrical Stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA system, but sufficient evidence regarding its outcomes and neural mechanisms have not been adequately investigated. An understanding of its neural underpinnings and analgesic effects could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3) development of new techniques to address pain.

Eligibility Criteria

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.

Inclusion Criteria

You need to be right-handed to keep the study results consistent.

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

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

+2 more

Exclusion Criteria

Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known.

Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.

Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.

+4 more

Participant Groups

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.

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.