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Radiation Therapy

Radiosurgery for Trigeminal Neuralgia

N/A
Waitlist Available
Led By John Fiveash, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an ECOG status of 0, 1, or 2
Patients must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing the use of a new technique for treating trigeminal neuralgia, a type of nerve pain.

Who is the study for?
This trial is for adults with trigeminal neuralgia, a type of facial pain, that's not improved with medication. They should be in stable health (ECOG 0-2), have more than a year to live, and an MRI confirming their pain isn't caused by other issues. It's not for those who've had brain radiation before or have certain conditions like multiple sclerosis.Check my eligibility
What is being tested?
The study tests a frameless radiosurgery technique called Virtual Cone on people with trigeminal neuralgia. Participants will receive an 80 Gy dose of radiation aimed at reducing facial pain without the need for physical head frames used in traditional treatments.See study design
What are the potential side effects?
Potential side effects may include skin redness, swelling around the treatment area, fatigue, headaches, and temporary worsening of facial pain. Long-term risks might involve nerve damage leading to numbness or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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My facial pain is severe and not improved with medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.
Secondary outcome measures
Mean of Quality of Life Scores as measured by SF-36 Questionnaire
Number of Participants with treatment-related adverse events
Patient Satisfaction Scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: 80 Gy Radiation & Unframed Virtual ConeExperimental Treatment2 Interventions
80 Gy Virtual Cone Radiosurgery unframed (face mask)

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,004 Total Patients Enrolled
John Fiveash, MD3.85 ReviewsPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
5 Previous Clinical Trials
296 Total Patients Enrolled

Media Library

Unframed Virtual Cone (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02708810 — N/A
Trigeminal Neuralgia Research Study Groups: 80 Gy Radiation & Unframed Virtual Cone
Trigeminal Neuralgia Clinical Trial 2023: Unframed Virtual Cone Highlights & Side Effects. Trial Name: NCT02708810 — N/A
Unframed Virtual Cone (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02708810 — N/A
Trigeminal Neuralgia Patient Testimony for trial: Trial Name: NCT02708810 — N/A

Frequently Asked Questions

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

How many participants has this clinical trial recruited thus far?

"Affirmative. Clinicaltrials.gov contains information confirming that this clinical trial, first posted on November 1st 2015, is still recruiting patients and has been recently updated on September 12th 2022. Specifically, the study seeks to enroll 100 individuals at a single research site."

Answered by AI

Is geriatric participation accepted for this trial?

"This research endeavour is open to participants aged 18 and above, up until the age of 99."

Answered by AI

Who would be eligible to join this clinical research program?

"To be considered for this research, applicants need to have been diagnosed with trigeminal neuralgia and should range between 18-99 years of age. In total, the study aims to accept a sample size of 100 volunteers."

Answered by AI

Is the enrollment period for this trial still open?

"In accordance with the clinicaltrials.gov database, this trial is actively accepting participants and was first uploaded on November 1st 2015. The most recent edit to its record occurred on September 12th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Hazelrig-Salter Radiation Oncology Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've had tn on the left side of my face for 8 years. Now, it also is on the right side. Meds and nefve blocks, etc. have not worked for me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
John Fiveash, MD 2015. "RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02708810.
All > Paid Studies Alabama > Trigeminal Neuralgia
~6 spots leftby Oct 2025
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