Trigeminal Neuralgia
Conditions
Keywords
tic douloureux
Brief summary
Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.
Detailed description
Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. Pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed. Patients will be treated in a single session with 75 Gy maximal dose covering a 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Treatment will be delivered using the CyberKnife Robotic Radiosurgery System with the patient in the supine position. An aquaplast head mask will be used to ensure adequate immobilization during therapy. The target volume shall be the 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Patients will receive subcutaneous injection of amifostine (500 mg) or placebo 30 minutes +/- 30 minutes prior to SRS. Facial pain will be assessed using the Visual Analog Scale and Short-form McGill Pain Questionnaire. Following SRS, patients will be followed at 1, 3, 6, and 9 months ±7 days. Facial numbness will be assessed using the Barrow Neurologic Institute (BNI) Facial Numbness Score. Patient reported BNI facial numbness scoring and complete cranial nerve exam by a physician will be performed pre-treatment and at follow-up visits.
Interventions
DRUGAmifostine
Amifostine and CyberKnife stereotactic radiosurgery
PROCEDURECyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are: * Intolerant of or refractory to medical management; AND * Not candidates for or refusing a surgical micro-vascular decompression.
Exclusion criteria
* Patients who present with pre-existing BNI grade III or IV facial numbness. * Patients who have previously been treated with MVD. * Patients who have previously had an ablative treatment, including prior SRS. * Pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Numbness Following Radiosurgery | 1 year | Percent of patients with facial numbness following radiosurgery will be determined at one year follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief Following Radiosurgery | 1 year | Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication) |
Countries
United States
Participant flow
Recruitment details
Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. During their visit, a physician or research coordinator will explain the study. Patients will be given the informed consent form to read. If they agree to participate, they will be asked to sign the consent form prior to participating.
Pre-assignment details
Patient's pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo and SRS
CyberKnife stereotactic radiosurgery + saline | 9 |
| Amifostine Amifostine and CyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery + amofostine | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Placebo | Amifostine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 9 participants | 8 participants | 17 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
Primary
Facial Numbness Following Radiosurgery
Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.
Time frame: 1 year
Population: One subject randomized to drug arm did not have data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Facial Numbness Following Radiosurgery | 7 Participants |
| Amifostine | Facial Numbness Following Radiosurgery | 6 Participants |
Secondary
Pain Relief Following Radiosurgery
Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)
Time frame: 1 year
Population: 8 subjects were enrolled on the Amifostine arm, however, one subject was enrolled but withdrew prior to treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Pain Relief Following Radiosurgery | 9 Participants |
| Amifostine | Pain Relief Following Radiosurgery | 5 Participants |
p-value: 0.175Fisher Exact