Noninvasive Modulation of Chronic Neuropathic Pain

Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Device: Active stimulation using low-frequency ultrasonic transducer; Device: Sham stimulation using low-frequency ultrasonic transducer

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active stimulation; Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction	Device: Active stimulation using low-frequency ultrasonic transducer; The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
Sham Comparator: Sham stimulation; Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction	Device: Sham stimulation using low-frequency ultrasonic transducer; The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity: momentary change	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).	During the intervention, and every day thereafter, for 7 days
Pain intensity: subjective state	PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.	Immediately after the intervention, and every day thereafter, for 7 days

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Jan Kubanek, PhD, University of Utah; Study Chair: Daniel Odell, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2024
• Primary Completion (Actual): February 10, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia
• Other Study ID Numbers: IRB_00175546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No