Noninvasive Modulation of Chronic Neuropathic Pain

Chronic Pain Clinical Trial

Official title:

Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06249724
• Other study ID #: 00175546
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: Jan Kubanek, PhD
• Phone: 801-213-1418
• Email: jan.kubanek[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Active stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
• Sham stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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