Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 22 and 74 years old.
Select...
I have had severe pain for over 6 months.
Select...
My trigeminal neuralgia has not improved with medication.
Select...
My usual treatments for facial nerve pain haven't worked, including an anticonvulsant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment related adverse events
Secondary outcome measures
Change in pain intensity
Change in patient's perception of the effect of the procedure
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.
Find a Location
Who is running the clinical trial?
InSightecIndustry Sponsor
89 Previous Clinical Trials
3,704 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,646 Total Patients Enrolled
Focused Ultrasound FoundationOTHER
15 Previous Clinical Trials
304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than a year.Your skull density ratio is lower than 0.4 plus or minus 0.05.I do not have life-threatening conditions like HIV or liver failure.You have behaviors that show you may have problems with drinking alcohol or using drugs, as defined by certain guidelines.You have a weakened immune system, such as being HIV positive.I can stay still on my back for up to 4 hours.I am between 22 and 74 years old.My blood pressure is very high despite taking medication.I have not had severe depression, bipolar disorder, or suicidal thoughts in the last year.I have a brain tumor or a recent brain problem.I have had a seizure in the last year.I have Trigeminal Neuralgia and standard surgeries didn't work or aren't suitable for me.My scans show I can have a specific brain surgery.I have stable heart health and no recent heart attacks.I have been diagnosed with multiple sclerosis.You can tell the doctor how you feel during the Exablate TcMRgFUS treatment.My trigeminal neuralgia has not improved with medication.I have had severe pain for over 6 months.I am on blood thinners or have a bleeding disorder.I have not had a stroke or multiple strokes in the last 6 months.My usual treatments for facial nerve pain haven't worked, including an anticonvulsant.You have had a thalamic deep brain stimulation (DBS) implant in the past or currently have one.I am pregnant or could become pregnant and am not using birth control.I have had a brain bleed, brain injury, or stroke in a specific part of my brain.I have Trigeminal Neuralgia and standard surgeries didn't work or aren't suitable for me.
Research Study Groups:
This trial has the following groups:- Group 1: ExAblate Transcranial treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Trigeminal Neuralgia Patient Testimony for trial: Trial Name: NCT04579692 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment confined to those over 75 years of age?
"According to the qualifications for this clinical trial, eligible participants must be aged 21 or older and no more than 75 years old."
Answered by AI
How large is the cohort of participants included in this research endeavor?
"Affirmative. The information on clinicaltrials.gov reveals that this test is currently recruiting volunteers, with an initial post date of February 20th 2021 and a recent update dated March 17th 2022. Ten participants are needed from one site for the study's completion."
Answered by AI
Does this study accept new participants?
"To qualify for this trial, individuals must possess trigeminal neuralgia and be aged between 21 and 75. This research will accept a total of 10 enrollees."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
New York
Pennsylvania
Other
How old are they?
18 - 65
65+
What site did they apply to?
University of Maryland Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've tried 3 medications and have 3 rhizotomies with no lasting relief. I HAVE TRIED EVERYTHING I CAN AND CAN'T GET ANY RELIEF. I NEED HELP PLEASE.
PatientReceived 2+ prior treatments
I'm tired of being sick and being in pain. I just want to get off of some of these medications so I can feel like myself again.
PatientReceived 2+ prior treatments
I've had 3 nerve blocks on left side. They didn't work. They then burned the nerve, in 2017, which has caused numbness on left side of face. Now I'm having trouble with right side. Will have nerve block this next week. Meds have not worked.
PatientReceived 1 prior treatment
I've had trigeminal neuralgia on the left side for about 8 years. In 2017, a doctor burned the nerve, but in the process has caused numbness on the left side of my face, that's never gone away. About 2 months ago, the TN is now also on the right side. Medications have not helped. I will have a nerve block in a couple of weeks. I've just been grasping at straws trying to find some relief. Thanks.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
HOW LONG WOULD I NEED TO BE ON SITE? What exactly is being done in this trial for TN?
PatientReceived 2+ prior treatments
How many times will I have to travel to Baltimore?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- University of Maryland Medical Center: < 24 hours
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger