Chronic Pain, Neuropathic Pain
Conditions
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.
Interventions
DEVICEActive stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
DEVICESham stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity: momentary change | 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 | 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. |
Countries
United States
Outcome results
None listed