Noninvasive Modulation of Chronic Neuropathic Pain

NCT06249724 | Withdrawn Phase 1

• 1 other identifier: IRB_00175546
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction

Device: Active stimulation using low-frequency ultrasonic transducer

Sham stimulation

SHAM COMPARATOR

Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction

Device: Sham stimulation using low-frequency ultrasonic transducer

Interventions

Active stimulation using low-frequency ultrasonic transducer DEVICE

The ultrasonic transducer delivers focused low-intensity ultrasound stimulation

Active stimulation

Sham stimulation using low-frequency ultrasonic transducer DEVICE

The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Kubanek, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Daniel Odell, MD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: February 10, 2024
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)