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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Active Comparator | Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction |
|
| Sham stimulation | Sham Comparator | Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active stimulation using low-frequency ultrasonic transducer | Device | The ultrasonic transducer delivers focused low-intensity ultrasound stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Kubanek, PhD | University of Utah | Principal Investigator |
| Daniel Odell, MD | University of Utah | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| Sham stimulation using low-frequency ultrasonic transducer | Device | The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |