Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Facial Neuropathy
About this trial
This is an interventional treatment trial for Facial Neuropathy focused on measuring pain, neuropathic, face, trigeminal
Eligibility Criteria
Inclusion Criteria: 18-60 years of age Right-handed non-smokers Diagnosed with facial pain Continuous pain for more than 3 months Spontaneous pain greater than 3 of 10 Allodynia to brush greater than 5 of 10 Exclusion Criteria: Medications Depression Significant medical problems Claustrophobia Abnormal EKG Significant drug or alcohol history Positive drug screen Weight greater than 285 lbs History of allergy to anticonvulsants Tattoos with metallic ink on upper body Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas Exposure to shrapnel or metal filings Other metallic surgical hardware
Sites / Locations
- McLean Hospital Neuroimaging Center, 115 Mill Street
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Lamotrigine to Placebo Crossover
Placebo to Lamotrigine Crossover
The drug lamotrigine will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
The placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, the drug lamotrigine (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.