Focused Ultrasound for Fibromyalgia

Overseen By Akiko Okifuji, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SPIRE Therapeutics Inc.

Must not be taking: Ketamine, Esketamine

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new noninvasive brain treatment to determine its effectiveness in reducing pain for people with fibromyalgia. Participants will undergo four sessions of ultrasonic neuromodulation of the cingulate cortex (a type of brain stimulation) over a month and complete several surveys during the 16-week study. The trial includes two groups: one receiving the real treatment and the other receiving a sham (placebo) treatment. It suits those who have had fibromyalgia for at least three months, experience widespread body pain, and have not found relief from at least two different medications or therapies like exercise or cognitive therapy. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could potentially improve the quality of life for fibromyalgia patients.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you must have been on the same psychiatric treatment for at least one month before the trial and be willing to stay on it during the study unless a change is recommended by the investigator.

What prior data suggests that this noninvasive brain stimulation intervention is safe for fibromyalgia?

Research has shown that focused ultrasound, a noninvasive method to stimulate the brain, is generally well-tolerated. Past studies did not report any serious side effects. Minor issues, such as mild discomfort, typically resolved within 24 hours. This suggests the treatment is likely safe for participants. However, discussing any concerns with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultrasonic neuromodulation for fibromyalgia because it offers a new way to manage this often debilitating condition. Unlike traditional treatments like medications, which can have various side effects, this approach uses targeted sound waves to influence brain activity, specifically in the cingulate cortex, which is associated with pain processing. This technique is non-invasive and has the potential to provide relief without the need for drugs, making it a promising alternative for those who haven't found success with existing therapies. Additionally, the use of a sham treatment in trials helps ensure that any observed benefits are truly due to the neuromodulation itself.

What evidence suggests that ultrasonic neuromodulation of the cingulate cortex might be an effective treatment for fibromyalgia?

Research has shown that focused ultrasound on a specific part of the brain can help relieve fibromyalgia pain. In this trial, participants will join either an active treatment group receiving ultrasonic neuromodulation of the cingulate cortex or a sham treatment group. This method targets pain pathways without requiring surgery. Participants experienced mild side effects that disappeared within a day. Evidence suggests this approach can lessen pain and improve quality of life for those with fibromyalgia. Although a newer treatment, early results are promising. ^{1 2 3 4 5}

Who Is on the Research Team?

Akiko Okifuji, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with fibromyalgia who haven't found relief from at least two medications and physical or CBT therapy. They must have a consistent pain score of ≥4, be on stable psychiatric treatment, and not pregnant. Exclusions include certain mental health risks, substance abuse issues, MRI contraindications, other serious medical conditions, recent changes in pain treatment or specific therapies.

Inclusion Criteria

Stated willingness and ability to comply with all study procedures

Negative urine pregnancy test at screening for participants who could potentially become pregnant

Agreement to use a highly effective method of contraception for participants who could potentially become pregnant

Exclusion Criteria

Clinically significant neurodevelopmental, neurocognitive, or personality disorder

Moderate-High Risk of Suicide

Lifetime history of a serious suicide attempt

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four treatments of noninvasive brain stimulation over the course of one month

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, completing surveys at multiple time points

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasonic Neuromodulation of Cingulate Cortex

Trial Overview The study tests focused ultrasound as a noninvasive brain stimulation method to reduce fibromyalgia pain. Participants will undergo four treatments over one month and complete surveys during the 16-week study to assess effectiveness compared to sham (placebo) control.

How Is the Trial Designed?

Group I: Focused Ultrasound Active Control 1 Intervention

Group II: Sham Ultrasound Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

SPIRE Therapeutics Inc.

Lead Sponsor

University of Utah Data Coordinating Center

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226648

Ultrasonic Neuromodulation of Cingulate Cortex for ... The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11562753/

Noninvasive targeted modulation of pain circuits with focused ... The stimulation was well tolerated, and no adverse events were detected. Side effects were generally mild and resolved within 24 hours. Together ...

3. fusfoundation.org fusfoundation.org/diseases-and-conditions/fibromyalgia/

Fibromyalgia ... focused ultrasound produces neuromodulation effects that appear to be helpful in this complicated disease. The target is the cingulate cortex.

4. meddatax.com meddatax.com/clinical-trials/NCT07226648

A Blinded Randomized Sham-Controlled Trial The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001359

Low-intensity focused ultrasound to the posterior insula ... LIFU to the posterior insula reduced pain ratings during temporal summation of pain but not conditioned pain modulation.