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Focused Ultrasound

Focused Ultrasound for Trigeminal Neuralgia

N/A

Recruiting

Led By Dheeraj Gandhi, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Age greater than 21 and less than 75 years

Documented chronic, severe pain for more than 6 months duration

Must not have

Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc

Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, non-invasive way to treat Trigeminal Neuralgia that uses ultrasound waves to target and heat up the pain-conducting nerves. The goal is to see if this treatment is safe and effective.

Who is the study for?

This trial is for adults aged 21-75 with chronic, severe facial pain from Trigeminal Neuralgia that hasn't improved after standard treatments including anticonvulsants and possibly surgery. Candidates must be able to give consent, attend all visits, communicate during treatment, and have a feasible central lateral thalamotomy based on imaging.

What is being tested?

The study tests the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) in treating Trigeminal Neuralgia. This non-invasive technique uses sound waves directed at the brain area responsible for the pain under MRI guidance.

What are the potential side effects?

Potential side effects may include discomfort or pain during treatment, headache, nausea, numbness or tingling in the face or other areas treated by MRgFUS. More serious but rare risks could involve bleeding or damage to surrounding brain tissue.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 74 years old.

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I have had severe pain for over 6 months.

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My trigeminal neuralgia has not improved with medication.

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My usual treatments for facial nerve pain haven't worked, including an anticonvulsant.

Exclusion Criteria

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

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I do not have life-threatening conditions like HIV or liver failure.

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I can stay still on my back for up to 4 hours.

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I have not had severe depression, bipolar disorder, or suicidal thoughts in the last year.

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My blood pressure is very high despite taking medication.

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I have a brain tumor or a recent brain problem.

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I have had a seizure in the last year.

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I have stable heart health and no recent heart attacks.

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I have been diagnosed with multiple sclerosis.

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I am on blood thinners or have a bleeding disorder.

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I have not had a stroke or multiple strokes in the last 6 months.

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I am pregnant or could become pregnant and am not using birth control.

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I have had a brain bleed, brain injury, or stroke in a specific part of my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment related adverse events

Secondary study objectives

Change in pain intensity

Change in patient's perception of the effect of the procedure

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: ExAblate Transcranial treatmentExperimental Treatment1 Intervention

The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called central lateral thalamic nucleus. Ultrasound passes through the skin and skull and into the brain to focus on this particular spot.

0 / 16Eligibility criteria met