Ultrasonic Brain Stimulation for Fibromyalgia

(BEAMforFMS Trial)

Overseen By Madison Bunnell, Research Study coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

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: 14

Duration: 2 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat fibromyalgia by using low-intensity ultrasound to stimulate the brain. The goal is to determine if this noninvasive treatment can relieve the chronic pain linked to fibromyalgia. Participants will receive either the actual ultrasound treatment or a sham treatment, which feels the same but does not involve ultrasound. This trial suits individuals who have experienced widespread pain for at least three months and have tried at least two medications and physical therapy methods without success. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research in fibromyalgia treatment.

What prior data suggests that this ultrasound device is safe for brain stimulation?

Research has shown that low-intensity ultrasound brain stimulation could be a promising treatment for fibromyalgia. Studies have found that this noninvasive brain stimulation can reduce pain without the side effects often seen with medications, suggesting it is generally well-tolerated.

One study discovered that using low-intensity focused ultrasound on specific brain areas helped reduce pain levels. This indicates the treatment positively affects pain management, which is crucial for people with fibromyalgia. Additionally, early research—conducted before human testing—suggests that this ultrasound treatment can change pain-related behaviors without causing harmful effects.

Since the ultrasound device is still under study and not yet approved by the FDA for fibromyalgia, more research is needed. However, these initial findings are encouraging and suggest that the treatment is fairly safe for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard medications for fibromyalgia, such as pain relievers and antidepressants, low-intensity ultrasound brain stimulation offers a new, non-invasive approach that targets the brain directly. This method uses sound waves to potentially alter brain activity linked to pain perception, which is different from the way most current treatments manage symptoms. Researchers are excited about this technique because it could offer a novel, drug-free option that might reduce side effects and improve quality of life for patients.

What evidence suggests that this ultrasound device is effective for fibromyalgia?

Research shows that gentle ultrasound waves on the brain might help reduce pain for people with fibromyalgia. In earlier studies, patients experienced significant pain relief after several sessions of this brain treatment. Another study found that focusing the ultrasound on specific brain areas lowered pain levels. This trial will compare participants receiving low-intensity ultrasound brain stimulation with those in a sham control group, who will undergo the same procedure without ultrasound stimulation. This method appears to help the brain manage pain more effectively, offering hope for those with fibromyalgia. Although more research is needed, early results suggest it could be a promising way to manage pain. ^{1 2 3 6 7}

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 individuals with fibromyalgia, a condition characterized by widespread musculoskeletal pain. Participants must be able to attend seven in-person sessions and complete online assessments. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have been diagnosed with fibromyalgia, regardless of other health conditions.

I regularly do exercises such as walking, cycling, or swimming.

My pain and symptom scores meet the trial's required levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person or virtual)

Daily Pain Rating

Participants rate their average and worst pain over two consecutive days

2 days

2 virtual assessments

Treatment

Participants undergo 6 treatment sessions with low-intensity ultrasound or sham stimulation

2 weeks

6 visits (in-person)

Follow-up

Participants complete online symptom questionnaires to monitor safety and effectiveness

8 weeks

5 virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• Low-intensity ultrasound brain stimulation

Trial Overview

The study tests a new noninvasive brain stimulation using ultrasound, comparing it against no treatment (sham). It involves MRI scans, six treatment sessions over two weeks, and multiple online assessments before and after treatments.

How Is the Trial Designed?

Group I: Ultrasound Group Experimental Treatment 1 Intervention

Participants in this group will receive low-intensity ultrasound brain stimulation

Group II: Sham control Placebo Group 1 Intervention

Participants in this group will undergo the same procedure with the Ultrasound group but do not receive ultrasound stimulation

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10620708/

Non-invasive brain stimulation for fibromyalgia - PMC

In the case of fibromyalgia patients, they continued to experience significant pain relief following 10 or more consecutive sessions of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07361328

Personalized Ultrasonic Brain Stimulation for Fibromyalgia

The primary purpose of this research is to evaluate a new kind of noninvasive brain stimulation intervention using the investigational ultrasound device, ...

3.

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.

4.

pmc.ncbi.nlm.nih.gov

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

The efficacy and mechanisms of low-intensity transcranial ...

Current research indicates that LITUS targeting various brain regions, including IC, THAL, S1, ACC, and PAG could improve various pain metrics.

5.

biorxiv.org

biorxiv.org/content/10.1101/2022.12.07.519518v2.full.pdf

Low-intensity transcranial focused ultrasound suppresses ...

The preclinical results presented here showcase a unique bidirectional modulation of pain-. 13 associated behaviors through tailored tFUS ...

6.

ashpublications.org

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

Low-intensity transcranial focused ultrasound suppresses ...

These data suggest that 1-hour tFUS daily stimulation for 14 days with a PRF of 40 Hz at S1HL or insula can induce a sustained amelioration (2 ...

7.

fusfoundation.org

fusfoundation.org/diseases-and-conditions/neuropathic-pain/

Neuropathic Pain

A clinical trial is using low intensity focused ultrasound to do deep brain stimulation to help patients with chronic pain. Virginia ...