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.
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.
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.
Crossover
Primary Motor Cortex Stimulation
DeviceShort (\<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).
Occipital Lobe Stimulation
DeviceShort (\<1 ms), high amplitude (\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.
Feasibility of the transcranial electrical stimulation protocol
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
Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%).
Acceptability of transcranial electrical stimulation protocol
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)
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.
Revised Fibromyalgia Impact Questionnaire (FIQR)
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)
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)
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.
Number of steps
Assess change in number of steps taken daily using a wearable device.
Active zone minutes
Assess change in number of minutes spent in active heart rate zone using a wearable device.
Sleep score
Assess change in sleep quality using a wearable device.
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Pulkit Grover
Lead sponsor
Carnegie Mellon University
Sponsor institution
Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh
Collaborator
University of Pittsburgh Clinical and Translational Science Institute (CTSI)
Collaborator
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