Noninvasive Modulation of Chronic Neuropathic Pain
WithdrawnPhase 1, Phase 2NCT06249724
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves
- Conditions
- Interventions
- Device: Active stimulation using low-frequency ultrasonic transducer
- Device: Sham stimulation using low-frequency ultrasonic transducer
- Sponsor
- University of Utah
- Start date
- 2024-02-10
- Primary completion
- 2024-02-10
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06249724