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: Recruiting

Administrative data

• NCT number: NCT06249724
• Other study ID #: IRB_00175546
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 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: 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
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

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