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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment that uses sound waves directed at specific parts of the brain to help reduce pain. It targets patients with ongoing neuropathic pain that hasn't been managed well by other treatments. The sound waves aim to improve the function of brain areas that process pain signals. This noninvasive treatment option has shown promise in treating chronic neuropathic pain.

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 data supports the effectiveness of the treatment Focused Ultrasound for neuropathic pain?

Research shows that focused ultrasound can help reduce neuropathic pain by affecting nerve activity. In studies with animals, it has been shown to lower pain sensitivity and improve pain-related behaviors. Additionally, a study with human patients found that focused ultrasound reduced pain levels without causing side effects. ^{1 2 3 4 5}

Is focused ultrasound generally safe for treating neuropathic pain?

Focused ultrasound has been shown to be generally safe in humans, with mild and temporary side effects like tenderness and redness. In a study for neuropathic pain, no serious side effects were reported, making it a promising noninvasive treatment option. ^{1 3 4 6 7}

How does the treatment Focused Ultrasound differ from other treatments for neuropathic pain?

Focused Ultrasound is unique because it is a non-invasive treatment that uses sound waves to target specific nerve areas, potentially providing pain relief without damaging the nerves. Unlike traditional pain medications or invasive procedures, it can temporarily block nerve signals, offering a novel approach to managing neuropathic pain. ^{1 2 3 5 8}

Research Team

Sheldon Jordan, MD

Principal Investigator

Neurological Associates of West Los Angeles

Eligibility Criteria

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 am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Ireland 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. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

External focused ultrasound treatment for neuropathic pain induced by common peroneal nerve injury. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

An Ultrasonic Tool for Nerve Conduction Block in Diabetic Rat Models. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Low-Energy Transcranial Navigation-Guided Focused Ultrasound for Neuropathic Pain: An Exploratory Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Neuropathic tissue responds preferentially to stimulation by intense focused ultrasound. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of external low intensity focused ultrasound on electrophysiological changes in vivo in a rodent model of common peroneal nerve injury. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Intense Focused Ultrasound Preferentially Stimulates Transected Nerves Within Residual Limbs: Pilot Study. [2022]