Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain

This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.

Inclusion Criteria:Age 18-65, any genderPrimary diagnosis of generalized chronic pain or widespread chronic pain.Moderate-to-severe chronic pain lasting at least 2 monthsStated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the studyFor females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the studyCapacity to provide informed consent; provision of a signed and dated consent formExclusion Criteria:History of serious brain injury or other neurologic disorderPoorly managed general medical conditionPregnant or breast feedingImplanted device in the head or neckMRI intolerance or contraindicationBrain stimulation (e.g., VNS, TMS) in the past monthLifetime history of a serious suicide attempt (Hooley et al., 2014)Clinically inappropriate for participation in the study as determined by the study team