Noninvasive Modulation of Chronic Neuropathic Pain

University of Utah

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Neuropathic Pain Chronic Pain

Interventions

Active stimulation using low-frequency ultrasonic transducerDEVICE

The ultrasonic transducer delivers focused low-intensity ultrasound stimulation

Sham stimulation using low-frequency ultrasonic transducerDEVICE

The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Immediately after the intervention, and every day thereafter, for 7 days

Data from ClinicalTrials.gov

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