Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- University of Utah
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain intensity: momentary change
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
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.
Investigators
Jan Kubanek
Assistant Professor
University of Utah
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain intensity: momentary change
Time Frame: 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
Time Frame: 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.