RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

The University of Alabama at Birmingham

Status

Active, not recruiting

Conditions

Trigeminal Neuralgia

Treatments

Device: Unframed Virtual Cone

Radiation: 80 Gy Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02708810

IRB-150608005

Details and patient eligibility

About

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

Full 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).

Enrollment

40 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)