Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

The purpose of this study is to determine the effects of mild cranial electrical stimulation on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status in persons with fibromyalgia.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: CES device; Device: sham device

Detailed Description

Central pain networks in the brain are dysregulated in persons with fibromyalgia (FM). Thus, the investigators propose that cranial electrical stimulation (CES) that works on the brain may ameliorate symptoms of FM by interacting with the central pain networks. The specific aims of this randomized, controlled, three-group pilot study design are to: (1) determine differences in pain over time between the active CES, sham device, and usual care (UC) groups; (2) explore differences in brain activity in pain processing regions (i.e., cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the active CES, sham device, and UC groups in a subset of 12 participants (6 in each device group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances, depression, perceived stress) and functional status, and blood pressure over time between the active CES, sham device, and UC groups; and (4) determine the amount of influence that selected psychological factors (negative affect, catastrophizing, and other personality characteristics) have on group differences in pain, other symptoms, functional status, and brain activity.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Center for the Study of Complementary and Alternative Therapies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• meet the diagnostic criteria for FM established by the American College of Rheumatology
• have initial pain level equal to or greater than 3 on a NRS 0-10
• have stable medication use related to FM for at least 4 weeks
• be able to read, write, and understand the English language

Exclusion Criteria (all participants):

• pregnant or breastfeeding
• epilepsy or history of seizures
• presence of pacemakers and/or other implanted devices

Exclusion Criteria (subset of 12 participants who wil have fMRIs):

• conditions that would not permit an fMRI (e.g., certain types of metal or metallic objects in body, diaphragm or intrauterine device, dermal patches, ear or eye implants, implanted electrical stimulators, artificial heart valve, implanted catheter or tube, tattoos, claustrophobia; or weight more than 275 lbs)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CES device; Participants will use the device for 60 minutes each day for 8 weeks.	Device: CES device; Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.; Other Names: Alpha-Stim
Sham Comparator: Sham device; Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.	Device: sham device; The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.
No Intervention: Usual care alone; No intervention; participants will receive usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Using Numeric Rating Scale	A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Using Lee's Fatigue Scale	A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale	Week 8
General Sleep Disturbance Scale		Week 8
Depression Using the CES-D		Week 8
Perceived Stress Using Numeric Rating Scale		Week 8
Functional Status Using the Fibromyalgia Index Questionnaire		Week 8

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Ann G Taylor, EdD, RN, University of Virginia

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 24, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: functional magnetic resonance imaging; pain; fatigue; depression; fibromyalgia; sleep disturbance
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 14203