Noninvasive Modulation of Chronic Neuropathic Pain

Phase 1

Withdrawn

• Conditions: Neuropathic Pain; Chronic Pain
• Interventions: Device: Sham stimulation using low-frequency ultrasonic transducer; Device: Active stimulation using low-frequency ultrasonic transducer

• Registration Number: NCT06249724
• Lead Sponsor: University of Utah

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Start: 2024-02-10
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Primary diagnosis of 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

• Poorly managed general medical condition
• Pregnant or breast feeding
• Implanted device in the back
• Lifetime history of a serious suicide attempt
• Clinically inappropriate for participation in the study as determined by the study team

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Sham stimulation using low-frequency ultrasonic transducer	Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction
Active stimulation	Active stimulation using low-frequency ultrasonic transducer	Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction

Primary Outcome Measures

Name	Time	Method
Pain intensity: momentary change	During the intervention, and every day thereafter, for 7 days	Numerical Rating Scale (NRS-11) of pain. NRS-11 is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Pain intensity: subjective state	Immediately after the intervention, and every day thereafter, for 7 days	PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States