Noninvasive Modulation of Chronic Neuropathic Pain

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Neuropathic Pain; Chronic Pain

Treatments: Device: Sham stimulation using low-frequency ultrasonic transducer; Device: Active stimulation using low-frequency ultrasonic transducer

Study type: Interventional

Funder types: Other

Identifiers

NCT06249724

IRB_00175546

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Active stimulation

Active Comparator group

Description:

Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction

Treatment:

Device: Active stimulation using low-frequency ultrasonic transducer

Sham stimulation

Sham Comparator group

Description:

Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction

Treatment:

Device: Sham stimulation using low-frequency ultrasonic transducer