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.
Eligible Conditions
- Trigeminal Neuralgia
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 6 months
6 months
Change in pain intensity
Change in patient's perception of the effect of the procedure
Month 6
Incidence of Treatment related adverse events
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
ExAblate Transcranial treatment
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: ExAblate Transcranial treatment · No Placebo Group · N/A
ExAblate Transcranial treatment
Device
Experimental Group · 1 Intervention: ExAblate Transcranial treatment · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
634 Previous Clinical Trials
357,396 Total Patients Enrolled
Focused Ultrasound FoundationOTHER
12 Previous Clinical Trials
343 Total Patients Enrolled
InSightecIndustry Sponsor
87 Previous Clinical Trials
3,586 Total Patients Enrolled
Dheeraj Gandhi, MDPrincipal Investigator - University of Maryland School of Medicine
University of Maryland Medical Center, University of Maryland Radiation Oncology Associates PA
Maulana Azad Medical College (Medical School)
University Of Mi Hosps (Residency)
Eligibility Criteria
Age 21 - 75 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a type of facial pain called Classical or Idiopathic Trigeminal Neuralgia that has not improved with medication.
You have been experiencing severe pain for more than 6 months that has been documented.
You have Trigeminal Neuralgia and have already tried at least two different types of medication, including anticonvulsants, but didn't get better.
You have a condition called Trigeminal Neuralgia and have either tried standard treatments like surgery, radiofrequency, or radiosurgery, but they haven't worked. Or, you are not eligible for these treatments because of other health issues, the risk of anesthesia, or you have chosen not to undergo them even after counseling.
You are able to tell the doctor how you feel during the Exablate TcMRgFUS treatment.
Who else is applying?
What state do they live in?
| New York | 25.0% |
| North Carolina | 12.5% |
| Maryland | 12.5% |
| Other | 50.0% |
How old are they?
| 18 - 65 | 33.3% |
| 65+ | 66.7% |
What site did they apply to?
| University of Maryland Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 75.0% |
| Did not meet criteria | 25.0% |
Why did patients apply to this trial?
- "I HAVE TRIED EVERYTHING I CAN AND CAN'T GET ANY RELIEF. I NEED HELP PLEASE."
- "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."
- "I have Atypical TN with both constant, burning pain and intermittent/triggered, electric-shock like pain. I also have MS with lesions on my anterior Pons, which may be related to the condition. I have suffered wih the condition intermittently for 30 years, but it became difficult to live with in 2014, at which point i began a steady medication regimen (Gabapentin and Oxcarbazepine). Those reduced the frequency and severity until they began losing effectiveness in 2018, and attacks became constant/daily in August 2020. I have tried other medications (Amitryptiline, Duloxetine, Ativan, Prednisone, Ibuprofen, Naproxen), but none have been more than minimally effective at reducing the pain. I had stereotactic radiosurgery in July 2021, which was unsuccessful."
- "ive had trigeminal neuralgia for 24 years. luckily i have been in remission, is what i call it, for the last ten years. however, i have begun to get twinges and pain aching in my cheek, teeth, eye just the whole left side. I have tried medication in the past and it wasnt pleasant it made me a zombie were i couldnt function. the drs tried different combinations and it wasnt until acupuncture did i get relief. however, i moved and wasnt able to complete the long drive to the acupuncture dr and the pain returned so terrible that i was hospitalized for a week at UNC Chapel Hill. Once again so much medication it was be a zombie or be in pain. im also bipolar and was just diagnosed with major depressive disorder and im worried about the effects of the trigeminal medicine with those of my other conditions. I also have pharyngeal neuralgia and occipital neuralgia. it splits my whole head in half right down my nose to my throat when the pain is in full tilt, i cant breathe the air going into my nose burns and hurts i have to rock and breathe very slowly while holding my nose covering it. its very worrisome that i could end back in this state that is why i am reaching out to you today. thank you for your time and consideration."
How many prior treatments have patients received?
| 3+ | 100.0% |
What questions have other patients asked about this trial?
- "HOW LONG WOULD I NEED TO BE ON SITE?"
How responsive is this trial?
Most responsive sites:
- University of Maryland Medical Center: < 24 hours
Average response time
- < 1 Day
Typically responds via
| 100.0% | |
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer