What side effects are associated with this type of intervention?

Common treatments for pain similar to Low-Intensity Focused Ultrasound (LIFU) include ultrasound therapy and low-level laser therapy. Ultrasound therapy, often used in combination with other physical therapy modalities, has shown inconsistent results and is generally considered ineffective for chronic low back pain. Side effects are minimal but may include temporary discomfort or skin irritation. Low-level laser therapy has also yielded mixed results, with some studies showing pain relief and others not. Side effects are rare but can include mild skin reactions. Overall, these non-invasive treatments are generally well-tolerated with few adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pain management, including pharmacological options like opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and anticonvulsants such as gabapentin and pregabalin. Additionally, non-pharmacological treatments like transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS) have been approved for altering brain activity to manage pain. While Low-Intensity Focused Ultrasound (LIFU) is still under investigation, these existing treatments highlight the FDA's recognition of both drug-based and device-based approaches to pain management.

What other types of research exist?

Promising novel alternatives to Low-Intensity Focused Ultrasound (LIFU) for pain patients include: 1) Non-invasive neuromodulation, such as median and radial nerve stimulation, which has shown effectiveness in reducing tremor and pain. 2) Transcutaneous electrical nerve stimulation (TENS) combined with ultrasound therapy, which has been effective in treating chronic lumbar radiculopathy. 3) Adaptive devices for tremor reduction, including wearable robots and neuroprostheses that provide transcutaneous neurostimulation. These alternatives offer non-invasive options with demonstrated efficacy in clinical studies.

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Neuromodulation

Neuromodulation for Pain Management

N/A

Recruiting

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)

Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participant study duration, approximately 3 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial uses low-intensity focused ultrasound (LIFU) to gently stimulate specific areas of the brain. Focused ultrasound can stimulate a specific point of tissue and can be a noninvasive method for acupoint stimulation. It targets people dealing with addiction, pain, and mental health issues who may not respond well to typical treatments. The sound waves temporarily change brain activity, which could help improve their symptoms.

Who is the study for?

This trial is for healthy volunteers from any ethnic background who can understand and speak English. It's not suitable for pregnant individuals, those with certain metal implants, a history of significant head injury, claustrophobia, neurological disorders like Parkinson's or epilepsy, active central nervous system conditions such as Alzheimer's, or a history of substance dependence.

What is being tested?

The study tests how low-intensity focused ultrasound (LIFU) affects brain activity related to pain. Participants undergo MRI and CT scans along with LIFU treatment. Changes in brain signals are monitored through fMRI after LIFU while experiencing controlled heat sensations. The study spans over four visits including questionnaires and vital signs monitoring.

What are the potential side effects?

While the document doesn't specify side effects directly associated with LIFU in this context, typical concerns may include discomfort during imaging procedures or potential transient changes in brain function due to neuromodulation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like Parkinson's, Epilepsy, or Essential Tremor.

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I have a condition or am on treatment that affects my brain function.

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I have had a head injury that made me unconscious for more than 10 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participant study duration, approximately 3 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participant study duration, approximately 3 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participant study duration, approximately 3 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

fMRI BOLD Signals

Secondary study objectives

Changes in self-reported perceived pain

Other study objectives

Monitoring changes to physiological measures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LIFU, heat evoked fMRI signalsExperimental Treatment1 Intervention

fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common noninvasive treatments for pain, such as Low-Intensity Focused Ultrasound (LIFU), acupuncture, TENS, and ultrasound therapy, work by altering neural activity and modulating pain signals. LIFU temporarily changes brain activity, potentially affecting pain perception. Acupuncture may influence pain through changes in blood flow and neurotransmitter release. TENS uses electrical currents to disrupt pain signals to the brain, while ultrasound therapy heats deep tissues to reduce pain and inflammation. Understanding these mechanisms helps patients and clinicians choose appropriate treatments based on how they target pain pathways, potentially leading to more effective pain management.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.