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Noninvasive Modulation of Chronic Neuropathic Pain

NCT06249724 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-05-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jan Kubanek, PhD · University of Utah

  • Daniel Odell, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-10
Primary Completion
2024-02-10
Completion
2024-02-10

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249724 on ClinicalTrials.gov