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Procedure
Transcranial ExAblate for Trigeminal Neuralgia
N/A
Waitlist Available
Led By William J Elias, MD
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-treatment through 3 months following treatment.
Awards & highlights
Study Summary
This trial is testing a new treatment for chronic pain caused by trigeminal nerve damage. The treatment is safe and feasible so far.
Eligible Conditions
- Trigeminal Neuralgia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from pre-treatment through 3 months following treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-treatment through 3 months following treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Numeric Pain Rating Scale (NPRS)
Severity of Device and Procedure Related Complications
Secondary outcome measures
Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial ExAblateExperimental Treatment1 Intervention
ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)
Group II: Sham Transcranial ExAblatePlacebo Group2 Interventions
ExAblate MRgFUS Sham Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial ExAblate
2013
N/A
~80
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Who is running the clinical trial?
InSightecLead Sponsor
88 Previous Clinical Trials
3,694 Total Patients Enrolled
1 Trials studying Trigeminal Neuralgia
10 Patients Enrolled for Trigeminal Neuralgia
William J Elias, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 18 and 75 years old.Subjects who are able and willing to give consent and able to attend all study visits.You have temporomandibular joint syndrome.You have been experiencing severe, chronic pain in your facial nerves for at least 6 months.You have severe pain in the head or face caused by cancer in the head or neck area.You have a specific type of headache like migraine or cluster headache.You have unusual facial pain or pain caused by a condition related to how your body experiences and interprets physical sensations.You can tell the researchers how you feel during the ultrasound treatment.You have a type of facial pain called idiopathic trigeminal neuralgia.You have experienced pain that cannot be relieved by different treatments like injections, surgery, or others.You have been experiencing severe, long-lasting facial nerve pain for at least 6 months.You have severe nerve pain that has not responded well to at least three different prescription medications commonly used for pain relief, even when taken at the right dose.You have tried different treatments like injections, procedures, neuromodulation, and surgery for your pain, but none of them have helped.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Transcranial ExAblate
- Group 2: Transcranial ExAblate
Awards:
This trial has 0 awards, including: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: NCT03309813 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
After having covid my trigeminal pain increased to an unbearable level of pain. I need help.
PatientReceived no prior treatments
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