About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Primary Motor Cortex Stimulation
- Occipital Lobe Stimulation
Treatment groups
Locations
2Sponsors and collaborators
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