Phase
Condition
Chronic Pain
Fibromyalgia
Pain
Treatment
Sham stimulation with Diadem prototype
Verum stimulation with Diadem prototype
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-65, any gender
Primary diagnosis of generalized chronic pain or widespread chronic pain.
Moderate-to-severe chronic pain lasting at least 2 months
Stated willingness to comply with all study procedures and avoid changes to currenttreatments (medications, physical therapy, cognitive behavioral therapy) for theduration of the study
For females of reproductive potential: negative pregnancy test or use of highlyeffective contraception for at least 1 month prior to baseline; agreement to usesuch a method throughout the study
Capacity to provide informed consent; provision of a signed and dated consent form
Exclusion
Exclusion Criteria:
History of serious brain injury or other neurologic disorder
Poorly managed general medical condition
Pregnant or breast feeding
Implanted device in the head or neck
MRI intolerance or contraindication
Brain stimulation (e.g., VNS, TMS) in the past month
Lifetime history of a serious suicide attempt (Hooley et al., 2014)
Clinically inappropriate for participation in the study as determined by the studyteam
Study Design
Connect with a study center
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available

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