Focused Ultrasound for Neuropathic Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Scalp rash, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating neuropathic pain using focused ultrasound, a technique targeting specific brain areas to potentially improve pain control. The researchers aim to determine if this treatment is safe and effective for individuals who haven't found relief with at least three different pain medications. It suits those with ongoing neuropathic pain confirmed by imaging and who have tried treatments like antidepressants or opioids without success. Participants will undergo a brief ultrasound session targeting the brain's thalamus, guided by MRI scans. As an unphased trial, this study offers patients a unique opportunity to explore innovative treatment options that may provide relief where other methods have failed.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves participants who have failed at least three pharmacological treatments, it might be possible to continue your current medications.

What prior data suggests that focused ultrasound is safe for treating neuropathic pain?

Research has shown that focused ultrasound is generally safe for people with nerve pain. One study reported 12 mild or moderate side effects, indicating they were not serious. Importantly, no serious side effects occurred. After one year, patients experienced a significant reduction in pain, with levels dropping by 46.3%. These findings suggest that focused ultrasound is well-tolerated, with manageable side effects, and could be a promising option for pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about focused ultrasound for neuropathic pain because it offers a non-invasive way to target the brain's thalamus, which is a key area involved in pain processing. Unlike traditional treatments like medications or invasive surgeries, focused ultrasound uses sound waves to precisely target and potentially alter brain activity without making an incision. This approach could minimize side effects and recovery time, offering a quicker and potentially safer alternative to current options. Plus, the use of MRI and optical tracking for accuracy ensures the treatment is delivered exactly where it's needed, enhancing its potential effectiveness.

What evidence suggests that focused ultrasound is effective for neuropathic pain?

Research has shown that focused ultrasound, the treatment under study in this trial, can help reduce nerve-related pain. One study demonstrated that low-energy ultrasound on the brain effectively reduced pain in individuals with long-term conditions. Another study found that this technology could alter how the brain perceives pain, leading to relief. Additionally, focused ultrasound reduced pain behaviors in animal studies, indicating promise for its potential in humans. These findings suggest that targeting specific brain areas with focused ultrasound might offer relief from nerve-related pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Sheldon Jordan, MD

Principal Investigator

Neurological Associates of West Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults who have ongoing neuropathic pain, confirmed by imaging or sensory signs, and haven't found relief after trying at least three different medications like antidepressants, anticonvulsants, or opioids. It's not suitable for those unable to consent, stay still during treatment, pregnant or breastfeeding women, or individuals with scalp conditions.

Inclusion Criteria

I have tried at least 3 different medications for my condition without success.

I have experienced nerve pain, including when it started, where it hurts, how bad it is, how long it lasts, what it feels like, and what makes it worse.

I have confirmed nerve damage in a specific area of my body.

Exclusion Criteria

I have a scalp rash or open wounds on my scalp.

Pregnancy, women who may become pregnant or are breastfeeding

I cannot stay still when lying down in a calm environment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 consecutive weekly ultrasound sessions targeting the thalamus

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Focused Ultrasound

Trial Overview The study tests focused ultrasound technology on the VPM and VPL thalamic nuclei in the brain as a potential treatment for neuropathic pain. The goal is to see if this non-invasive method is tolerable and shows early signs of effectiveness in reducing pain symptoms.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the thalamus. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.

Focused Ultrasound is already approved in United States, European Union for the following indications:

Approved in United States as Gemzar for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer

Approved in European Union as Gemzar for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Published Research Related to This Trial

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

In a study involving 11 patients with chronic neuropathic pain, low-energy focused ultrasound (FUS) significantly reduced pain levels, with median current pain decreasing from 10.0 to 7.0 after 4 weeks, indicating its efficacy as a treatment.

The procedure was found to be safe, with no reported side effects such as burns or seizures, and no significant changes observed in follow-up brain imaging, suggesting that low-energy tcNgFUS is a noninvasive option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Energy Transcranial Navigation-Guided Focused Ultrasound for Neuropathic Pain: An Exploratory Study. Shin, DH., Son, S., Kim, EY.[2023]

In a study involving 30 male Sprague Dawley rats with common peroneal nerve injury, low intensity focused ultrasound (liFUS) applied to the L5 dorsal root ganglion significantly altered neuronal activity, increasing pyramidal neuron spike frequency in the primary somatosensory cortex (SI) and reducing interneuron firing in the anterior cingulate cortex (ACC).

These changes in neuronal activity occurred 80 to 120 minutes after liFUS treatment and may correlate with improved sensory thresholds, suggesting a potential mechanism for how liFUS can help alleviate neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of low intensity focused ultrasound on neuronal activity in pain processing regions in a rodent model of common peroneal nerve injury. Bao, J., Byraju, K., Patel, VJ., et al.[2022]

High intensity-focused ultrasound (HIFU) can temporarily and reversibly block nerve conduction in diabetic neuropathic rats without causing nerve damage, suggesting its potential for pain relief.

The study involved creating diabetic neuropathic models in rats and successfully demonstrated the ability of HIFU to suppress action potentials in these nerves, paving the way for future clinical applications in ultrasound-based pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Ultrasonic Tool for Nerve Conduction Block in Diabetic Rat Models. Lee, YF., Lin, CC., Cheng, JS., et al.[2019]

Citations

1. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-for-neuropathic-pain-us-clinical-trial-data-published/

Focused Ultrasound for Neuropathic Pain: US Clinical Trial ... Researchers at the University of Maryland Medical Center have published the final results from the first US clinical trial treating refractory neuropathic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10605299/

Low-Energy Transcranial Navigation-Guided Focused ... This prospective exploratory study showed that low-energy tcNgFUS could be used effectively in patients with chronic neuropathic pain. Low-energy FUS avoids ...

3. 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.

4. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-025-02096-y

The efficacy and mechanisms of low-intensity transcranial ... Active tFUS significantly attenuated thermal pain thresholds immediately after intervention, whereas no significant changes in sensory or ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12570825/

A panoramic review of transcranial focused ultrasound ... Low-energy transcranial navigation-guided focused ultrasound for neuropathic pain: an exploratory study. ... safety and tolerability outcomes ...

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

Neuropathic Pain Learn how focused ultrasound could transform the quality of life and decrease the cost of care for patients with Neuropathic Pain.

8. 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 ...