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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post final treatment (8 weeks from baseline)

Awards & highlights

Study Summary

This trial will test whether focused ultrasound can help people with neuropathic pain by targeting the VPM and VPL thalamus.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Brief Pain Inventory (BPI)

Numeric Pain Rating Scale (NPRS)

Patient Health Questionnaire (PHQ-9)

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neurological Associates of West Los AngelesLead Sponsor

25 Previous Clinical Trials

3,920 Total Patients Enrolled

Sheldon Jordan, MDPrincipal InvestigatorNeurological Associates of West Los Angeles

12 Previous Clinical Trials

2,550 Total Patients Enrolled

Media Library

Focused Ultrasound (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04485208 — N/A

Neuropathic Pain Research Study Groups: Active

Neuropathic Pain Clinical Trial 2023: Focused Ultrasound Highlights & Side Effects. Trial Name: NCT04485208 — N/A

Focused Ultrasound (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485208 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept participants aged 35 years or younger?

"As indicated by the trial's inclusion criteria, suitable candidates must be between 18 and 90 years old. Furthermore, 8 sub-trials are available for those under 18 whereas 144 studies will accept elderly patients above 65 years of age."

Answered by AI

Is enrollment for this research experiment presently open?

"According to clinicaltrials.gov, this study is not presently enrolling patients. The trial was first published on June 30th 2020 and the most recent update was made in September 26 2022. Though applicants are no longer being accepted for this particular research, there are currently 160 other studies that need participants."

Answered by AI

What criteria are being utilized to determine eligibility for this research project?

"This clinical study seeks to enrol 40 individuals aged 18-90 who are suffering from neuralgia. Other admittance requirements include: a documented history of neuropathic pain, confirmation of a neurological injury via imaging or sensory tests, failure in at least three pharmacological treatments and an appropriate age (18+)."

Answered by AI

Who else is applying?

What state do they live in?

Utah

What site did they apply to?

Neurological Associates of West LA

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I saw a segment on 60 minutes about ultra sound treatment for people with Alzheimer’s and drug addiction and thought I wonder if this could help with chronic pain. I searched online and found that it was a procedure that was in trials, and started searching for a trial I could into. I live in constant pain and daily life sucks, I’m just looking for some help.

PatientReceived 2+ prior treatments

Recent research and studies

Frontiers in Integrative NeuroscienceJournal

Role for the Ventral Posterior Medial/posterior Lateral Thalamus and Anterior Cingulate Cortex in Affective/motivation Pain Induced by Varicella Zoster Virus

Kramer, Phillip R., Jennifer Strand, Crystal Stinson, Larry L. Bellinger, Paul R. Kinchington, Michael B. Yee, Mikhail Umorin, and Yuan B. Peng. 2017. “Role for the Ventral Posterior Medial/posterior Lateral Thalamus and Anterior Cingulate Cortex in Affective/motivation Pain Induced by Varicella Zoster Virus”. Frontiers in Integrative Neuroscience. Frontiers Media SA. doi:10.3389/fnint.2017.00027.

BmjJournal

Neuropathic Pain: Mechanisms and Their Clinical Implications

Cohen, S. P., and J. Mao. 2014. “Neuropathic Pain: Mechanisms and Their Clinical Implications”. Bmj. BMJ. doi:10.1136/bmj.f7656.

The NeuroscientistJournal

Thinking Outside the Box (and Arrow): Current Themes in Striatal Dysfunction in Movement Disorders

Plotkin, Joshua L., and Joshua A. Goldberg. 2018. “Thinking Outside the Box (and Arrow): Current Themes in Striatal Dysfunction in Movement Disorders”. The Neuroscientist. SAGE Publications. doi:10.1177/1073858418807887.

Journal of Neurology, Neurosurgery & PsychiatryJournal