Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

NCT ID: NCT00928720

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-10-31

Brief Summary

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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

CES device

Participants will use the device for 60 minutes each day for 8 weeks.

Group Type: ACTIVE_COMPARATOR

CES device

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

sham device

Intervention Type: 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.

Usual care alone

No intervention; participants will receive usual medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Alpha-Stim

Eligibility Criteria

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

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Ann G Taylor

Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann G Taylor, EdD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for the Study of Complementary and Alternative Therapies

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

14203

Identifier Type: -

Identifier Source: org_study_id