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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, non-invasive treatment for individuals with ongoing, widespread pain. The treatment, Deep Brain Therapy, uses focused ultrasound to target specific brain areas linked to pain. Participants will receive either the actual ultrasound treatment or a sham version to determine the treatment's effectiveness. Suitable candidates have experienced moderate-to-severe generalized pain for at least two months and are willing to maintain their current treatments during the study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires you to avoid changes to your current treatments, including medications, for the duration of the study.

What prior data suggests that this non-invasive ultrasound brain therapy is safe for chronic pain?

Research has shown that low-intensity transcranial focused ultrasound stimulation is generally safe for people. A review found that most individuals tolerate this technique well, experiencing no major side effects. Studies have demonstrated its potential in treating brain and mental health conditions. One study found that this method can alter brain circuits related to pain, potentially reducing pain without surgery. Overall, current evidence supports its safety as a non-invasive brain treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about deep brain therapy for chronic pain because it uses low-intensity transcranial focused ultrasound to target specific areas of the brain involved in pain perception. Unlike traditional treatments like medications or invasive procedures, this method is non-invasive, meaning it doesn't require surgery or drugs. This unique approach could offer a safer and potentially more effective way to manage chronic pain with fewer side effects. Additionally, the use of focused ultrasound allows for precise targeting of brain regions, which could lead to more personalized pain management options.

What evidence suggests that this ultrasound brain therapy is effective for chronic pain?

This trial will evaluate the effectiveness of low-intensity transcranial focused ultrasound for chronic pain management. Research has shown that this therapy can reduce pain by targeting specific brain areas involved in pain perception. Studies have found that this approach can change pain-related behaviors in animals, suggesting potential effectiveness in humans. Specifically, focusing on areas like the anterior cingulate cortex, which connects to pain perception, has shown promising results. This non-invasive method alters how the brain processes pain, offering a potential new way to manage chronic pain. These findings suggest that this treatment could be effective for individuals dealing with ongoing pain. Participants in this trial will receive either active or sham stimulation to assess the therapy's impact. ^{1 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05674903

Deep Brain Therapy With Low-intensity Ultrasound for ... This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ...

2. ashpublications.org ashpublications.org/blood/article/144/10/1101/516866/Low-intensity-transcranial-focused-ultrasound

Low-intensity transcranial focused ultrasound suppresses ... Low-intensity transcranial focused ultrasound suppresses pain by modulating pain-processing brain circuits.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12281706/

The efficacy and mechanisms of low-intensity transcranial ... The efficacy of LITUS on pain were divided into four sections based on the targeted brain areas within the studies: anterior cingulate cortex ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S000649712401838X

Low-intensity transcranial focused ultrasound suppresses ... We demonstrate that tFUS stimulation at pain-processing brain circuits can significantly alter pain-associated behaviors in mouse models in vivo.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9879416/

Safety Review and Perspectives of Transcranial Focused ... This review aims to provide safety information and perspectives of tFUS brain stimulation. First, the acoustic parameters most relevant to ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763423004700

The effectiveness and safety of low-intensity transcranial ... Low-intensity transcranial ultrasound stimulation shows therapeutic effects in neurological and psychiatric disorders. •. Low-intensity transcranial ultrasound ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9599299/

Safety of Clinical Ultrasound Neuromodulation - PMC Transcranial ultrasound holds much potential as a safe, non-invasive modality for navigated neuromodulation, with low-intensity focused ultrasound (FUS) and ...