Non-invasive Ultrasound Brain Therapy for Chronic Pain

(DBT Trial)

Overseen By Akiko Okifuji, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Utah

Disqualifiers: Serious brain injury, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

47 Participants Needed

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 have had chronic pain for at least 2 months.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Low-intensity transcranial focused ultrasound stimulation delivered using a range of stimulation parameters during psychophysical and physiological monitoring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deep Brain Therapy

Trial Overview 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.

Participant Groups

Group I: Active stimulation Experimental Treatment 1 Intervention

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

Group II: Sham stimulation Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+