NCT05674903

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

Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Chronic Pain Syndrome
• Widespread Chronic Pain

Interventions

Type	Name	Description
DEVICE	Verum stimulation with Diadem prototype	Diadem prototype device delivers focused low-intensity ultrasound stimulation
DEVICE	Sham stimulation with Diadem prototype	Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2023-01-09
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States