Non-invasive Ultrasound Brain Therapy for Chronic Pain
(DBT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound 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 trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.

Eligibility Criteria

This trial is for adults aged 18-65 with a primary diagnosis of generalized chronic pain or widespread chronic pain that's moderate-to-severe and lasting at least 2 months. Participants must be willing to maintain current treatments without changes and, if female and able to conceive, use effective contraception. Exclusions include serious brain injury, other neurologic disorders, certain medical conditions, pregnancy, breastfeeding, head/neck implants, MRI issues or recent brain stimulation.

Inclusion Criteria

I agree to follow the study rules and not change my current treatments.

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

I am between 18 and 65 years old.

+3 more

Exclusion Criteria

I have an implanted device in my head or neck.

Clinically inappropriate for participation in the study as determined by the study team

Poorly managed general medical condition

+5 more

Participant Groups

The study tests a non-invasive deep brain therapy using low-intensity ultrasound (Diadem prototype) on individuals with chronic pain. It involves comparing real ('verum') stimulation against fake ('sham') in a blinded setup where neither the participants nor researchers know who receives which treatment until after the results are collected.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype

Group II: Sham stimulationPlacebo Group1 Intervention

Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype