What side effects are associated with this type of intervention?

Common treatments for neuropathic pain, such as transcranial magnetic stimulation (TMS) and spinal cord stimulation (SCS), have reported side effects that include lightheadedness, tingling, and tinnitus for TMS, and potential complications like motor blockade, urinary retention, and in rare cases, epidural hematoma for SCS. Non-invasive neuromodulation methods, such as transcutaneous electrical nerve stimulation (TENS) and scrambler therapy, may cause mild skin irritation, tingling, and muscle spasms. Overall, these treatments are generally well-tolerated, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for neuropathic pain, including pharmacological agents and neuromodulation techniques. Pharmacological treatments include anticonvulsants like pregabalin and gabapentin, and antidepressants such as duloxetine and amitriptyline. Neuromodulation techniques, similar to the focused ultrasound being studied, include spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS). These treatments aim to modulate neural activity to alleviate pain, similar to the mechanism proposed for focused ultrasound targeting the VPM and VPL thalamus.

What other types of research exist?

Promising novel alternatives to Focused Ultrasound for neuropathic pain include: 1) Spinal Cord Stimulation (SCS), which involves implanting a device to send electrical pulses to the spinal cord to reduce pain signals. 2) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in reducing pain intensity. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which involves stimulating the vagus nerve through the skin to modulate pain pathways. These alternatives have demonstrated efficacy in clinical trials and are available in various regions.

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Procedure

Focused Ultrasound for Neuropathic Pain

N/A

Waitlist Available

Led By Sheldon Jordan, MD

Research Sponsored by Neurological Associates of West Los Angeles

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

Failure from at least 3 pharmacological treatments (e.g., antidepressants, anticonvulsants, opioids)

Must not have

Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)

Subjects unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post final treatment (8 weeks from baseline)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not detailed here, focused ultrasound treatments may include discomfort at the site of application, headache or dizziness post-treatment. More serious but rare risks could involve unintended impacts on nearby brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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

Exclusion Criteria

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

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

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post final treatment (8 weeks from baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post final treatment (8 weeks from baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post final treatment (8 weeks from baseline) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Brief Pain Inventory (BPI)

Numeric Pain Rating Scale (NPRS)

Patient Health Questionnaire (PHQ-9)

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: ActiveExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focused Ultrasound

2012

Completed Phase 2

~50

0 / 5Eligibility 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 treatments for neuropathic pain include focused ultrasound, spinal cord stimulation, and pharmacological agents. Focused ultrasound targets the ventral posteromedial (VPM) and ventral posterolateral (VPL) thalamic nuclei to modulate neural activity, potentially reducing pain signals. Spinal cord stimulation involves delivering electrical impulses to the spinal cord to interfere with pain signal transmission. Pharmacological treatments, such as amitriptyline, pregabalin, and duloxetine, work by altering neurotransmitter levels to reduce pain perception. These treatments are crucial for neuropathic pain patients as they offer various mechanisms to disrupt the chronic pain cycle, providing relief and improving quality of life.