Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain (NCT05674903) | Clinical Trial Compass
CompletedPhase 1/2
Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
United States47 participantsStarted 2023-07-10
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
✓. For 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 study
✓. Capacity to provide informed consent; provision of a signed and dated consent form
Exclusion criteria
✕. History of serious brain injury or other neurologic disorder