50 Participants Needed

CES with Alpha-stim for Fibromyalgia

AW
Overseen ByAnna Woodbury, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research on cranial electrotherapy stimulation (CES) for fibromyalgia shows it is generally safe, with no negative side effects reported in studies. CES has been used successfully in clinical settings without safety concerns.12345

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?

AW

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

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.
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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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either true or sham cranial electrical stimulation (CES) weekly for 4 weeks

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 12 weeks post-treatment

12 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Alpha-stim
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

In a randomized controlled trial involving three groups (active CES device, sham device, and usual care), microcurrent cranial electrical stimulation (CES) therapy significantly reduced average pain, fatigue, and sleep disturbances in individuals with fibromyalgia, with notable p-values indicating effectiveness.
Participants using the active CES device also showed improved functional status compared to those using the sham device or receiving usual care, suggesting that CES therapy may be a beneficial treatment option for managing fibromyalgia symptoms.
Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia.Taylor, AG., Anderson, JG., Riedel, SL., et al.[2018]
A follow-up study of 69 fibromyalgia patients, conducted 45 months after a randomized controlled trial, showed significant long-term improvements in symptoms, with Fibromyalgia Impact Questionnaire scores decreasing from 52.6 at baseline to 31.8 at follow-up (P<.001).
Patients reported lasting benefits from noninvasive cortical stimulation therapy, including reduced medication use and fewer doctor visits for fibromyalgia, indicating the treatment's sustained efficacy.
Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation.Hargrove, JB., Bennett, RM., Clauw, DJ.[2015]
In a study involving 21 veterans with fibromyalgia, those receiving auricular percutaneous electrical nerve field stimulation (PENFS) showed a trend toward improved pain scores and significant reductions in pain interference with sleep compared to standard therapy alone after 12 weeks.
Neuroimaging results indicated that PENFS treatment was associated with increased connectivity in brain areas related to pain processing and executive control, suggesting a unique mechanism of action for PENFS in managing fibromyalgia symptoms.
Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial.Woodbury, A., Krishnamurthy, V., Gebre, M., et al.[2023]

Citations

Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. [2018]
Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. [2015]
The treatment of fibromyalgia with cranial electrotherapy stimulation. [2019]
Brain Modulation by Electric Currents in Fibromyalgia: A Structured Review on Non-invasive Approach With Transcranial Electrical Stimulation. [2022]
Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization. [2022]
Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. [2023]
Neural indices of multimodal sensory and autonomic hyperexcitability in fibromyalgia. [2023]
Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study. [2023]
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