CES with Alpha-stim for Fibromyalgia
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial requires that you do not start any new medications or treatments for fibromyalgia during the study, but it does not specify if you need to stop your current medications.
Is cranial electrotherapy stimulation (CES) with Alpha-stim safe for humans?
How does the Alpha-stim treatment differ from other treatments for fibromyalgia?
Alpha-stim treatment uses cranial electrotherapy stimulation (CES), which involves passing small electrical currents across the head through ear electrodes. This non-drug approach is unique because it targets the brain's pain processing and control systems, showing improvements in pain, sleep, and overall well-being without the negative side effects often associated with medications.23467
What data supports the effectiveness of the treatment Alpha-stim for fibromyalgia?
Research shows that cranial electrical stimulation (CES), like Alpha-stim, can reduce pain, fatigue, and sleep disturbances in fibromyalgia patients. Studies found significant improvements in pain and quality of life, with no negative side effects, suggesting CES is as effective as some drug therapies for fibromyalgia.12348
Who Is on the Research Team?
Anna Woodbury, MD
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either true or sham cranial electrical stimulation (CES) weekly for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 12 weeks post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alpha-stim
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor