Trigeminal Neuralgia Clinical Trial
TRIGEMINAL NEURALGIA
Trigeminal neuralgia (or tic doloureax) is one of the most common causes of facial pain. Patients describe stabbing, burning, electric shock-like pain that can involve the eyes, lips, nose, scalp, forehead, and jaw. Pain triggers include touching, chewing, talking, and brushing teeth. Pain attacks can last several seconds to hours and can repeat up to hundreds of times a day. This intense and often agonizing pain can be very debilitating for those who suffer from it.
The pain originates from the trigeminal nerve (fifth cranial nerve). It is thought that the most common cause of trigeminal neuralgia is the compression of the nerve root by a blood vessel. Other causes of trigeminal neuralgia include nerve compression by acoustic neuroma (vestibular schwannoma), meningioma, epidermoid cyst, or artieriovenous malformation.
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TREATMENT OPTIONS
Medications. Medications, such as anticonvulsants, muscle relaxants, narcotic pain medications, and antidepressants, are usually the first line of treatment. However, many people do not get adequate pain relief from medications or suffer from intolerable side effects of medications and need to seek other treatment options.
Surgery. Surgery relieves pain by either 1) relieving pressure on the nerve, or 2) selectively damaging the nerve:
Microvascular decompression is highly effective; up to 90% of the patients initially achieve pain relief. It is an invasive neurosurgery procedure such that elderly patients or patients with certain medical conditions may not be eligible. Risks of surgery may include decreased hearing, facial muscle weakness, facial numbness, double vision, infection, excessive bleeding, cerebrospinal fluid leak, stroke, and death.
Balloon compression, glycerol injection, and radiofrequency rhizotomy use needles or catheters inserted through the patient’s face to the opening in their base of skull to reach the trigeminal nerve. A lesion is created in the nerve using a mechanical balloon, chemical (glycerol), or heat, respectively. These three procedures are less invasive than open surgery. Initial pain relief can be achieved in the majority of patients treated, but the pain relief is often temporary as many patients experience pain recurrence. Facial numbness is a frequent side effect.
Stereotactic radiosurgery. Focused high dose radiation is used to treat the trigeminal nerve. Long-term pain relief can be achieved in the majority of patients treated. Stereotactic radiosurgery systems, such as the CyberKnife, gamma knife, and linear-accelerator based systems have been used.
STANFORD CYBERKNIFE STEREOTACTIC RADIOSURGERY CENTER: ADVANCING THE TREATMENT OF TRIGEMINAL NEURALGIA
Precisely targeted radiation is delivered to the trigeminal nerve using a completely non-invasive, painless out-patient procedure. There is no need for local or general anesthesia. Unlike frame-based stereotactic radiosurgery systems that require a head frame to be bolted onto the patient’s skull using aluminum or titanium screws, no head frame is needed with CyberKnife radiosurgery.
The Stanford CyberKnife radiosurgery technique has produced excellent clinical outcomes. Recently published results§ of the trigeminal neuralgia patients treated at Stanford using CyberKnife stereotactic radiosurgery have shown that 85% of the patients treated had complete resolution of pain within an average of 5 weeks. In most patients, pain relief began within the first week. Ninety-six percent (96%) of the patients graded their pain relief outcomes as excellent or good.
An example of a CyberKnife radiosurgical plan for trigeminal neuralgia. The left panel displays a 3-Dimensional reconstruction of the patient showing the approximately 130 radiation beams (light blue line) which intersect and target the trigeminal nerve. The right panel displays the trigeminal nerve (red line) treated with the intended radiation dose (green line).
§Adler JR, Bower R, Gupta G, Lim M, Efron A, Gibbs IC, Chang SD, Soltys SG. Nonisocentric radiosurgical rhizotomy for trigeminal neuralgia. Neurosurgery 64 (2 Supp):A84-90, 2009.
CLINICAL TRIALS FOR TRIGEMINAL NEURALGIA WITH CYBERKNIFE AVAILABLE ONLY AT STANFORD:
Our goals are to provide improved treatments and enhance the lives of patients with trigeminal neuralgia. To this end, we offer the following clinical trials. These studies are available only at Stanford.
Clinical Trial 1 - Can You Have Pain Relief WITHOUT Side Effects?
As with many treatments for trigeminal neuralgia, facial numbness is a potential side effect after CyberKnife radiosurgery. Can a one-time dose of a medication protect you from the risk of facial numbness?
The goal of this study is to learn if using a radioprotectant drug (i.e., a drug that protects normal tissues from the side effects of radiation) given at the time of radiosurgery will reduce your risk of getting facial numbness. This is the first study of its kind; the results may change the paradigm of trigeminal neuralgia treatments in the future.
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Clinical Trial 2 - How Does CyberKnife Radiosurgery Relieve Pain?
Radiosurgery has been used to relieve trigeminal neuralgia pain for multiple decades. While we know radiosurgery to be effective, the exact mechanism by which radiation causes pain relief is not well understood. We hope to answer this question using a novel MRI (Magnetic Resonance Imaging) technique. The knowledge gained using this method will help improve radiosurgery delivery in the future.
To learn more about this study, please see contact information below
CONTACT INFORMATION FOR CLINICAL TRIALS
For more information or to learn how to participate in a clinical trial for trigeminal neuralgia, please contact our clinical trials coordinator:
Julian Hong
Clinical Trials Coordinator
Department of Radiation Oncology Stanford University
julianhong@stanford.edu
(Tel) 650-736-0798