Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: CES device
* Device: sham device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CES device<br>Participants will use the device for 60 minutes each day for 8 weeks. | Device: CES device<br>* 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.<br>* Other names: Alpha-Stim;|
| Sham Comparator: Sham device<br>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<br>* The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.<br>|
| No Intervention: Usual care alone<br>No intervention; participants will receive usual medical care | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, pain, sleep disturbance, fatigue, depression, functional magnetic resonance imaging