CES with Alpha-stim for Fibromyalgia

Overseen By Anna Woodbury, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Implanted devices, Seizures, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a non-drug treatment for fibromyalgia, a chronic pain condition often managed with opioids. Researchers are testing Alpha-stim, a device using Cranial Electrical Stimulation (CES), to determine its effectiveness in reducing pain and improving quality of life without medication side effects. Participants will receive either real CES therapy or a sham (inactive) version, alongside standard care. Veterans diagnosed with fibromyalgia who experience daily pain might be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for fibromyalgia.

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.

What prior data suggests that this device is safe for fibromyalgia treatment?

Research has shown that Cranial Electrical Stimulation (CES) with the Alpha-stim device is generally safe. The FDA has approved this device, indicating it has passed safety checks. In studies involving fibromyalgia patients, CES was well-tolerated, with serious side effects being rare.

Most users do not experience major issues, though mild effects like headaches or dizziness can occur, typically resolving quickly. Research primarily examines how CES functions and its effectiveness in pain relief. So far, the safety data remains reassuring. For specific concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Alpha-stim for fibromyalgia because it introduces a non-invasive approach through cranial electrical stimulation (CES) using earclip electrodes. Unlike standard treatments like pain relievers, antidepressants, and physical therapy, which often require systemic administration or physical effort, Alpha-stim offers a targeted electrical intervention that participants can self-administer. This method aims to relieve pain by delivering a specific electrical current directly to the brain, potentially offering a new way to manage symptoms without the side effects associated with medications. The hope is that this approach can improve pain management, function, and quality of life more effectively than existing options.

What evidence suggests that CES with Alpha-stim is effective for fibromyalgia?

This trial will compare the effects of Cranial Electrical Stimulation (CES) using the Alpha-Stim device with a sham device for veterans with fibromyalgia. Studies have shown that CES with the Alpha-Stim device can reduce pain in people with fibromyalgia. In three studies, participants using the active CES device reported more pain relief than those using a sham (fake) device. Early results also suggest it might improve daily functioning. Although the FDA has approved CES as a non-drug therapy, researchers continue to explore its effects on the brain. Overall, the evidence is promising for those seeking alternatives to traditional pain medications. ^{1 4 6 7 8}

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

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.

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.

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?

Group I: True CES Experimental Treatment 1 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 CES Placebo Group 1 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.

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 study involving 38 fibromyalgia patients, high-definition transcranial alternating current stimulation (HD-tACS) showed a significant reduction in the fibromyalgia impact questionnaire (FIQ) scores after two weeks, indicating potential benefits in managing symptoms.

Despite the positive findings, there were no significant differences in pain intensity compared to sham stimulation, and while most side effects were mild, one serious adverse event (a suicide attempt) raises safety concerns that need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study. Lin, AP., Chiu, CC., Chen, SC., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. Woodbury, A., Krishnamurthy, V., Gebre, M., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Hargrove, JB., Bennett, RM., Clauw, DJ.[2015]

Citations

1. alpha-stim.com alpha-stim.com/research-and-reports/the-treatment-of-fibromyalgia-with-cranial-electrotherapy-stimulation/?srsltid=AfmBOop06FkwsapBFEUACfnyKor4m_j0bw3ZzUtCmeH6m1TXFNRnVi6K

The treatment of fibromyalgia with cranial electrotherapy ... There was no statistically significant difference at baseline between active CES and sham treatment groups on any of the 12 outcome measures. Data Analysis In ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493135/

The Effectiveness and Risks of Cranial Electrical Stimulation ... All 3 studies of patients with fibromyalgia reported statistically significant benefits in active CES with an Alpha-Stim device as compared to sham treated ...

3. alpha-stim.com alpha-stim.com/research-and-reports/the-effect-of-cranial-electrotherapy-stimulation-ces-on-pain-associated-with-fibromyalgia/?srsltid=AfmBOoodwHF713cVmw7B4mT6GPvlstmZiLqpsyb5iXaansLtrh0wSZl8

The effect of cranial electrotherapy stimulation (CES) on ... There were no statistically significant differences at baseline between active CES and sham treatment groups for any of the outcome measures. Data Analysis Data ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04115033

Randomized Controlled Trial of CES for Fibromyalgia Preliminary results reveal a trend towards improved pain and function with a FDA-approved, non-pharmacologic therapy - auricular Cranial Electrical Stimulation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11908385/

A Randomized, Sham-Controlled Trial of Cranial Electrical ... This is a randomized, placebo-controlled trial to determine the efficacy of CES for improving pain and function in fibromyalgia

6. alpha-stim.com alpha-stim.com/research-and-reports/the-treatment-of-fibromyalgia-with-cranial-electrotherapy-stimulation/?srsltid=AfmBOooGzGgQZZEvGOcMWIp8XHGhbYt1HoCTn9x1M3FajTUVrjjdkvC0

The treatment of fibromyalgia with cranial electrotherapy ... There was no statistically significant difference at baseline between active CES and sham treatment groups on any of the 12 outcome measures. Data Analysis In ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00928720

Cranial Electrical Stimulation Effects on Symptoms in ... The purpose of this study is to determine the effects of mild cranial electrical stimulation on pain, fatigue, sleep disturbances, perceived stress, blood ...

8. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/CES-REPORT.pdf

The Effectiveness and Risks of Cranial Electrical Stimulation ... We identified a small number of RCTs of the use of CES for a handful of painful conditions: fibromyalgia, headache, SCI-associated pain, painful degenerative ...