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Ultrasound Therapy

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

Phase 1 & 2
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 18-65, any gender
Must not have
Implanted device in the head or neck
History of serious brain injury or other neurologic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day at mri study visit

Summary

This trial will test a new non-invasive therapy for chronic pain, using MRI and pain rating scales to measure its effects.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a non-invasive procedure involving ultrasound waves directed at the brain through the skull there may be minimal side effects; however specific risks will depend on individual responses to ultrasound exposure but could potentially include discomfort at site of application or transient headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to follow the study rules and not change my current treatments.
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I am between 18 and 65 years old.
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I have had chronic pain for at least 2 months.
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I have been diagnosed with widespread chronic pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an implanted device in my head or neck.
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I have had a serious brain injury or neurological disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day at mri study visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day at mri study visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety scale: subjective state
Depression scale: subjective state
Pain intensity: momentary change
+3 more

Trial Design

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

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,788 Total Patients Enrolled
28 Trials studying Chronic Pain
4,793 Patients Enrolled for Chronic Pain

Media Library

Deep Brain Therapy (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05674903 — Phase 1 & 2
Chronic Pain Research Study Groups: Active stimulation, Sham stimulation
Chronic Pain Clinical Trial 2023: Deep Brain Therapy Highlights & Side Effects. Trial Name: NCT05674903 — Phase 1 & 2
Deep Brain Therapy (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674903 — Phase 1 & 2
~20 spots leftby Mar 2026
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