RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

  • STATUS
    Recruiting
  • End date
    Oct 16, 2025
  • participants needed
    100
  • sponsor
    University of Alabama at Birmingham
Updated on 16 September 2022
MRI
ache
facial pain

Summary

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

Description

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).

Details
Condition Trigeminal Neuralgia
Treatment Unframed Virtual Cone, 80 Gy Radiation
Clinical Study IdentifierNCT02708810
SponsorUniversity of Alabama at Birmingham
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
Patients must have an ECOG status of 0, 1, or 2
Patients must be at least 18 years of age
Life expectancy must be greater than 12 months
MRI of brain within prior 12 months to confirm lack of other causes of facial pain
All patients must be given written informed consent

Exclusion Criteria

Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
Patients with atypical trigeminal neuralgia or headache pain syndromes
Patients with pain associated with multiple sclerosis or base of skull tumor
Patients with medical contra-indications to MR imaging (e.g. pacemaker)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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