NCT06249724

Noninvasive Modulation of Chronic Neuropathic Pain

Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. The 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 level of pain will be evaluated using the Numerical Rating Scale (NSR-11) and the Patient-Reported Outcomes Measurement Information System (PROMIS) numerical rating scales of pain.

Conditions

• Neuropathic Pain
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Active stimulation using low-frequency ultrasonic transducer	The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
DEVICE	Sham stimulation using low-frequency ultrasonic transducer	The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation

Timeline

• Start date: 2024-02-10
• Primary completion: 2024-02-10
• Completion: 2024-02-10
• First posted: 2024-02-08
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States