LIFU for Chronic Pain

Overseen By Wynn Assistant Professor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Claustrophobia, Neurologic disorder, Alcohol dependence, others

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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment using sound waves can help people with chronic pain. Participants will receive noninvasive brain stimulation called low-intensity focused ultrasound (LIFU), which aims to temporarily alter brain activity. The study compares the effects of real and placebo (sham) LIFU treatments, while monitoring brain activity and collecting feedback on pain levels. It is suitable for individuals who have experienced moderate to severe chronic pain for at least three months and can tolerate MRI scans. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new pain management solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an active medical disorder or treatment that affects the central nervous system, you may be excluded from participating.

What prior data suggests that this noninvasive brain stimulation technique is safe for chronic pain patients?

Research has shown that Low-Intensity Focused Ultrasound (LIFU) is generally safe. Studies have progressed from basic research to clinical trials, indicating that LIFU is usually well-tolerated. Early results suggest that targeting certain brain areas with LIFU can help reduce pain, potentially managing pain without major side effects. Although more research is needed to confirm these findings, current evidence is promising for those considering participation in a clinical trial involving LIFU. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LIFU (Low-Intensity Focused Ultrasound) for chronic pain because it offers a non-invasive and potentially safer alternative to traditional pain management options like opioids and NSAIDs. Unlike these medications, which often come with significant side effects and dependency risks, LIFU uses sound waves to target specific areas of the brain associated with pain, potentially reducing pain perception without the need for drugs. This novel approach could provide faster relief and a new avenue for individuals who have not found success with existing treatments.

What evidence suggests that LIFU is effective for chronic pain?

Research has shown that low-intensity focused ultrasound (LIFU) might reduce pain by temporarily altering brain activity. Some studies have found that targeting specific brain areas with LIFU can lower pain levels in certain tests. For instance, applying LIFU to the posterior insula, a brain area involved in processing pain, reduced pain during specific tests. Early evidence suggests that LIFU might help with central sensitization, a condition where the nervous system becomes overly sensitive to pain. This trial will compare the effects of active LIFU application, known as Verum LIFU, with a Sham LIFU application to determine its effectiveness in calming overactive pain signals in the brain and aiding chronic pain management. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have been experiencing moderate-to-severe chronic pain for at least three months. Participants must understand and speak English, but people of all ethnicities are welcome.

Inclusion Criteria

I have had moderate-to-severe chronic pain for at least 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Participants undergo MRI and CT scans, complete questionnaires, and undergo QST testing

1 visit

1 visit (in-person)

Intervention

Participants receive sham or verum LIFU application with quantitative sensory testing and physiological data collection

1 visit

1 visit (in-person)

Follow-Up Imaging

Participants receive resting-state MRI scans following intervention sessions

4 weeks

Up to 4 visits (in-person)

Follow-Up Virtual Questionnaires

Participants complete virtual questionnaires to rate pain and report lifestyle impacts

2 weeks

At least 2 times per week

Second Intervention and Follow-Up

Participants undergo a second intervention visit after a minimum 4-week washout period, followed by a 3-week follow-up period

3 weeks

1 visit (in-person) for intervention, follow-up virtual questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• LIFU

Trial Overview The study is testing the effects of low-intensity focused ultrasound (LIFU) on chronic pain by comparing it with a sham procedure. It involves brain scans, temperature-induced pain tests, monitoring vital signs, and completing questionnaires over ten weeks.

How Is the Trial Designed?

Group I: Verum LIFU Experimental Treatment 1 Intervention

Active LIFU application with 3 week follow-up (MRI, questionnaires)

Group II: Sham LIFU Placebo Group 1 Intervention

Sham application of LIFU - all follow up (MRI, questionnaires) will be identical.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Focused Ultrasound Foundation

Collaborator

Trials

18

Recruited

460+

Published Research Related to This Trial

In a pilot study involving 22 patients with chronic neuropathic pain, electroacupuncture (EA) significantly reduced pain intensity by 46.7% after 4 weeks of treatment, indicating its potential effectiveness as an add-on therapy.

Patients reported improvements in specific pain types, such as burning and electric shock-like pain, along with enhanced psychosocial well-being, suggesting that EA not only alleviates pain but also improves quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture May Improve Burning and Electric Shock-Like Neuropathic Pain: A Prospective Exploratory Pilot Study. Lee, S., Lee, CS., Moon, JY., et al.[2021]

Internal qigong significantly reduced chronic pain compared to control groups, with a notable effect size of -1.23, indicating its potential as an effective treatment option.

External qigong showed some benefits but did not consistently outperform control or waiting list groups, suggesting that more rigorous studies are needed to confirm its efficacy in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Qigong for Adults with Chronic Pain: Systematic Review and Meta-Analysis. Bai, Z., Guan, Z., Fan, Y., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40599994/

Low-intensity focused ultrasound of the spine in ... In this work, we review current advances in LIFU of the spine region for the treatment of chronic neuropathic pain and movement disorders.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06906211

Low Intensity Focused Ultrasound for Chronic Pain: High ... The preliminary data indicate that LIFU to PI reduces laboratory measures of central sensitization and evoked pain in healthy controls but there was no such ...

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. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2025.1606672/full

Low-intensity focused ultrasound of the spine in ... In this work, we review current advances in LIFU of the spine region for the treatment of chronic neuropathic pain and movement disorders.

5. fusfoundation.org fusfoundation.org/posts/chronic-pain-and-depression-two-focused-ultrasound-clinical-trials-published/

Chronic Pain and Depression: Two ... SPIRE's DIADEM device uses focused ultrasound neuromodulation to stimulate the areas of the brain affected by chronic pain and depression.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700779/

A Comprehensive Review of Low-Intensity Focused ... Regardless, given LIFU has revealed a strong safety profile, research is rapidly moving beyond basic mechanistic studies to clinical trials to ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924006627

A Comprehensive Review of Low-Intensity Focused ... Regardless, given LIFU has revealed a strong safety profile, research is rapidly moving beyond basic mechanistic studies to clinical trials to assess its impact ...

8. ashpublications.org ashpublications.org/blood/article/144/10/1035/517565/Lowering-pain-with-LIFU

Lowering pain with LIFU | American Society of Hematology Focal delivery of low-intensity focused ultrasound (LIFU) to known “pain centers” in the brain can reduce pain-related behaviors (hyperalgesia) in a humanized ...