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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, and 12 weeks following treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 willing and able to understand and participate in this study.
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I am a Veteran aged 20-60 diagnosed with fibromyalgia.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Pain Change
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,546 Total Patients Enrolled
5 Trials studying Fibromyalgia
651 Patients Enrolled for Fibromyalgia
Anna Woodbury, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Fibromyalgia
27 Patients Enrolled for Fibromyalgia

Media Library

Alpha-stim (Cranial Electrical Stimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04115033 — N/A
Fibromyalgia Research Study Groups: Sham CES, True CES
Fibromyalgia Clinical Trial 2023: Alpha-stim Highlights & Side Effects. Trial Name: NCT04115033 — N/A
Alpha-stim (Cranial Electrical Stimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04115033 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollees currently being admitted to this clinical trial?

"Data on clinicaltrials.gov affirms that this study is actively enrolling participants, having first been posted on March 2nd 2020 and last updated on April 3rd 2022."

Answered by AI

Does this trial encompass individuals aged 25 and above?

"The investigators of this trial are seeking participants who are between the ages of 20 and 60."

Answered by AI

How many participants is the research team aiming to enroll in this trial?

"Affirmative. According to the clinicaltrials.gov page, 50 participants are being sought for this trial which was posted on March 2nd 2020 and last updated four days later. Just one site is included in the recruitment process."

Answered by AI

Am I eligible to join in the research for this clinical trial?

"This clinical trial is seeking 50 individuals aged between 20 and 60 who are suffering from fibromyalgia. All applicants must ensure they meet the following prerequisites: intact skin on the electrode placement site, right-handedness to maintain brain structure uniformity, male or female veteran status with a clinician's diagnosis of fibromyalgia according to American College of Rheumatology 2010 criteria., daily pain (greater than 5 on VAS) that has been present for more than 90 days and an agreement to participate in this study while understanding all associated consent forms."

Answered by AI
~6 spots leftby Sep 2024