Low-Intensity Focused Ultrasound for Various Conditions

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Polytechnic Institute and State University

Must be taking: Buprenorphine, Methadone

Must not be taking: Daily opiates

Disqualifiers: Neuropathic pain, Schizophrenia, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be in treatment for opioid use disorder with buprenorphine or methadone, so you may need to continue those medications.

What data supports the effectiveness of the treatment Low-Intensity Focused Ultrasound (LIFU)?

Research shows that Low-Intensity Focused Ultrasound (LIFU) can enhance drug delivery in liver tumors and improve chemotherapy effectiveness in brain metastases, suggesting its potential in treating various conditions. ^{1 2 3 4 5}

How is Low-Intensity Focused Ultrasound (LIFU) treatment different from other treatments?

Low-Intensity Focused Ultrasound (LIFU) is unique because it uses sound waves to target specific areas in the body without surgery, making it a non-invasive option. Unlike other treatments that may require incisions or drugs, LIFU focuses energy precisely to treat conditions, potentially reducing recovery time and side effects. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for individuals with chronic pain, opioid use disorder, and anxiety disorders. The eligibility criteria are not fully listed here, so additional requirements may apply.

Inclusion Criteria

I have widespread pain with a high severity score.

Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5

I am currently being treated for opioid addiction with buprenorphine or methadone.

Exclusion Criteria

I have been diagnosed with a brain condition or abnormality by a neuroradiologist.

I have been diagnosed with schizophrenia or schizo-affective disorder.

Pregnant or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low Intensity Focused Ultrasound (LIFU) or Sham treatment and complete measures of pain, craving, and anxiety pre and post intervention

4 weeks

Multiple visits

Follow-up

Participants are monitored for changes in heart rate, mood, respiration rate, and blood pressure, and for treatment-emergent adverse events

4 weeks

Treatment Details

Interventions

• Low-Intensity Focused Ultrasound (Procedure)

Trial Overview The study investigates the effects of Low-Intensity Focused Ultrasound (LIFU) on reducing pain, cravings related to opioid use, and symptoms of anxiety in patients with these conditions.

Participant Groups

Group I: Pain, Craving, and Anxiety measures Experimental Treatment 2 Interventions

Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Washington DC VA Medical Center

Collaborator

Trials

2

Recruited

100+

Salem VA Medical Center

Collaborator

Trials

2

Recruited

30+

Findings from Research

The combination of adriamycin-microbubble-PLGA nanoparticle complexes (ADM-NMCs) with low-intensity focused ultrasound (LIFU) significantly enhanced tumor inhibition in rabbits with VX2 liver tumors, resulting in the highest volume inhibition rate and apoptotic index compared to other treatment groups.

Rabbits treated with ADM-NMCs and LIFU had the longest median survival time of 71 days, indicating that this method not only targets the tumor effectively but also improves overall survival, showcasing a promising approach for localized chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity focused ultrasound mediated localized drug delivery for liver tumors in rabbits. Gong, Y., Wang, Z., Dong, G., et al.[2018]

High-density gel polymer matrices are effective couplants for low-intensity focused ultrasound (LIFU) neuromodulation, showing low acoustic attenuation (3.3%) and minimal beam distortion, making them suitable for clinical use.

The study highlights the importance of using standardized methods for preparing these gels to ensure consistent performance, as factors like thickness and de-gassing can significantly affect acoustic transmission and pressure attenuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. Strohman, A., In, A., Stebbins, K., et al.[2023]

Low-intensity focused ultrasound (LiFUS) significantly enhances the accumulation of chemotherapy drugs in brain metastases, which is crucial for treating metastatic breast cancer, as traditional therapies have low efficacy.

In a preclinical model, combining LiFUS with chemotherapy (Doxil and paclitaxel) resulted in a median survival of 60 days and slower tumor progression compared to other treatment combinations, suggesting that LiFUS could be a promising strategy for improving drug delivery to brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-tumor barrier opening by MRI-guided transcranial focused ultrasound in a preclinical breast cancer brain metastasis model improves efficacy of combinatorial chemotherapy. Arsiwala, TA., Blethen, KE., Wolford, CP., et al.[2023]

In a study of 20 patients with inoperable pancreatic cancer, high-intensity focused ultrasound (HIFU) significantly reduced pain levels, with an average decrease of 2.87 points on the numeric rating scale (NRS) and a 57.3% reduction from baseline in 19 out of 20 patients.

HIFU not only alleviated physical pain but also significantly improved emotional pain aspects, demonstrating its effectiveness as a palliative treatment option for managing pain in advanced pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High-intensity focused ultrasound (HIFU) for tumor pain relief in inoperable pancreatic cancer : Evaluation with the pain sensation scale (SES)]. Marinova, M., Strunk, HM., Rauch, M., et al.[2022]

Low-intensity focused ultrasound (LIFU) treatment significantly improved spasticity in male Sprague-Dawley rats with spinal cord injury after 4 weeks of daily sessions, indicating its potential as an effective therapy.

The mechanism of LIFU's efficacy may involve a reduction in the expression of growth associated protein 43 (Gap43), suggesting it helps to modulate neuroplasticity and axon regeneration below the injury site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proteomics Reveals the Effect of Low-Intensity Focused Ultrasound on Spasticity After Spinal Cord Injury. Wang, B., Zhao, H., Chen, M., et al.[2023]

In a study using bovine liver, the accuracy of ultrasound monitoring for tissue necrosis caused by pulsed high intensity focused ultrasound (PHIFU) was significantly improved by using a correlation function-based evaluation, which achieved an 85% accuracy rate compared to only 51% for gray-scale evaluations.

This suggests that relying solely on gray-scale changes in ultrasound images is insufficient for accurately monitoring tissue damage during PHIFU treatment, highlighting the need for more sensitive evaluation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Accuracy of correlation function method for evaluating pulsed high intensity focused ultrasound]. Zhao, X., Zou, J., Wu, F., et al.[2016]

Pulsed high-intensity focused ultrasound (PHIFU) was found to create greater liquefaction necrosis in liver tissue compared to continuous high-intensity focused ultrasound (CHIFU) at the same energy dose, indicating its potential for more effective tissue ablation.

PHIFU at a duty cycle of 60% showed lower energy efficiency compared to CHIFU, but it may enhance tissue destruction through cavitation effects, suggesting that optimizing duty cycles could improve ablation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Pulsed Versus Continuous High-Intensity Focused Ultrasound Ablation Using In Vitro and In Vivo Models. Wang, Y., Wang, Q., Luo, Y., et al.[2020]

In a study involving 10 patients with various skin lesions, 20 MHz high-intensity focused ultrasound (HIFU) demonstrated a 97% cure rate for actinic keratosis (AK), with most lesions healing within 1-2 weeks and no scarring observed.

HIFU was found to be effective and safe for treating AK and showed potential for use in basal cell carcinoma and Kaposi sarcoma, suggesting it could be a promising alternative or supplement to traditional photodynamic therapy (PDT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. Serup, J., Bove, T., Zawada, T., et al.[2021]

High-intensity focused ultrasound (HIFU) is an effective non-invasive treatment for various solid tumors, including liver and pancreatic cancers, particularly beneficial for patients who cannot undergo surgery due to medical complications.

HIFU serves as a valid treatment option for liver tumors in patients with poor liver function and is also used as a bridging therapy for those awaiting liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of high-intensity focused ultrasound. She, WH., Cheung, TT., Jenkins, CR., et al.[2017]

In a clinical trial involving 152 healthy patients, high-intensity focused ultrasound (HIFU) was found to be a safe method for reducing localized abdominal fat, with no serious device-related adverse events reported.

The treatment effectively targeted subcutaneous adipose tissue, leading to normal healing and minimal discomfort, with optimal results achieved at lower energy levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel high-intensity focused ultrasound device for ablating subcutaneous adipose tissue for noninvasive body contouring: safety studies in human volunteers. Gadsden, E., Aguilar, MT., Smoller, BR., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Low-intensity focused ultrasound mediated localized drug delivery for liver tumors in rabbits. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Blood-tumor barrier opening by MRI-guided transcranial focused ultrasound in a preclinical breast cancer brain metastasis model improves efficacy of combinatorial chemotherapy. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[High-intensity focused ultrasound (HIFU) for tumor pain relief in inoperable pancreatic cancer : Evaluation with the pain sensation scale (SES)]. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

Proteomics Reveals the Effect of Low-Intensity Focused Ultrasound on Spasticity After Spinal Cord Injury. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Accuracy of correlation function method for evaluating pulsed high intensity focused ultrasound]. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Comparative Study of Pulsed Versus Continuous High-Intensity Focused Ultrasound Ablation Using In Vitro and In Vivo Models. [2020]

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

High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. [2021]

9. China pubmed.ncbi.nlm.nih.gov

Clinical applications of high-intensity focused ultrasound. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of a novel high-intensity focused ultrasound device for ablating subcutaneous adipose tissue for noninvasive body contouring: safety studies in human volunteers. [2016]