Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
CompletedPhase 1, Phase 2NCT05674903
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
- Interventions
- Device: Verum stimulation with Diadem prototype
- Device: Sham stimulation with Diadem prototype
- Sponsor
- University of Utah
- Start date
- 2023-07-10
- Primary completion
- 2024-08-28
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age 18-65, any gender 2. Primary diagnosis of generalized chronic pain or widespread chronic pain. 3. Moderate-to-severe chronic pain lasting at least 2 months 4. 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 5. 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 6. Capacity to provide informed consent; provision of a signed and dated consent form Exclusion Criteria: 1. History of serious brain injury or other neurologic disorder 2. Poorly managed general medical condition 3. Pregnant or breast feeding 4. Implanted device in the head or neck 5. MRI intolerance or contraindication 6. Brain stimulation (e.g., VNS, TMS) in the past month 7. Lifetime history of a serious suicide attempt (Hooley et al., 2014) 8. Clinically inappropriate for participation in the study as determined by the study team
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05674903