Fibromyalgia (FM)
Conditions
Keywords
Transcranial Electrical Stimulation, Noninvasive Brain Stimulation, Fibromyalgia, Chronic Pain, Pulsed Transcranial Electrical Stimulation
Brief summary
The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are: Do repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life? Researchers will compare different brain targets to see if effects are different between them. Participants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.
Detailed description
Participants will randomly receive primary motor cortex (M1) or occipital lobe NIBS over 2 weeks, and after a wash-out period will receive NIBS of the other target over 2 weeks. Each session will also evaluate pressure pain algometry, various questionnaires to assess changes in fibromyalgia symptoms and quality of life (up to 5 hours per session) NIBS administration will consist of 1000 electrical pulses of \<1 ms duration each.
Interventions
Short (\<1 ms), high amplitude (\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).
DEVICEOccipital Lobe Stimulation
Short (\<1 ms), high amplitude (\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.
Sponsors
Pulkit Grover
Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh
University of Pittsburgh Clinical and Translational Science Institute (CTSI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Formal diagnosis of fibromyalgia made by a practicing physician * Pain resistant to common analgesics and medications for chronic pain * Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS) * Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.
Exclusion criteria
* If the subject is non-ambulatory. * If the subject is female of child-bearing potential, subject must not be pregnant. * Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack. * Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease. * Subject must not have any implanted electronic or metallic devices. * Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV/AIDS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the transcranial electrical stimulation protocol | From end of the last study session until up to 6 months after. | Feasibility of the protocol will be measured quantitatively using the Feasibility of Intervention Measure (FIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of feasibility. It will also be assessed qualitatively via participant interviews. |
| Tolerability of transcranial electrical stimulation protocol | Every day from enrollment until up to 6 months after the last study session. | Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%). |
| Acceptability of transcranial electrical stimulation protocol | From end of the last study session until up to 6 months after. | Acceptability of the protocol will be measured quantitatively using the Acceptability of Intervention Measure (AIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of acceptability. It will also be assessed qualitatively via participant interviews. |
| Pressure pain threshold (PPT) | At every study session from Session 1 until the last study session. | PPT (in lbf) will be measured using a digital algometer, which will be used to press down on the participants' thumb nails and legs to assess pain sensitization throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQR) | Weekly from enrollment until up to 6 months after the last study session. | FIQR will be used to assess the participant's experience with fibromyalgia (symptoms and impact on daily life). Score ranges from 0 to 100, with higher scores indicating greater severity of fibromyalgia symptoms and functional impairment. |
| Brief Pain Inventory (BPI) | Daily, from enrollment until up to 6 months after the last study session. | BPI will be used to assess the participant's pain severity and interference. Score ranges from 0 to 10, with higher scores indicating worse (more severe) pain or interference. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Weekly, from enrollment until up to 6 months after the last study session. | We will use the standardized survey score PROMIS-29 to assess physical and mental health in seven domains (e.g., physical function, anxiety, sleep disturbance etc.). Each question score ranges from one to five, corresponding to the intensity within the question's domain. Survey scores will be converted to a t-score metric and assessed. |
Countries
United States
Contacts
CONTACTPulkit Grover, PhD
CONTACTBenedict J Alter, PhD
PRINCIPAL_INVESTIGATORPulkit Grover, PhD
Carnegie Mellon University
PRINCIPAL_INVESTIGATORBenedict J Alter, MD, PhD
University of Pittsburgh
Outcome results
None listed