Clinical trial NCT00243152: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Official title: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Neuropathy
Keywords: pain
neuropathic
face
trigeminal
Lead sponsor: Pain and Analgesia Imaging and Neuroscience Group
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-10-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).

Detailed description: Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. The administration of lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.

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

Primary outcomes:
measure: Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States
timeFrame: Week 10 during scanning session
Secondary outcomes:
measure: Subjective Ratings of Pain During Magnetic Resonance Scanning
timeFrame: week 10 (during the scan)
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital Neuroimaging Center, 115 Mill Street
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: David Borsook, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becerra L, Breiter HC, Wise R, Gonzalez RG, Borsook D. Reward circuitry activation by noxious thermal stimuli. Neuron. 2001 Dec 6;32(5):927-46. doi: 10.1016/s0896-6273(01)00533-5.
citation: Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens LE. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain. 1997 Nov;73(2):223-230. doi: 10.1016/S0304-3959(97)00104-8.
citation: Petersen KL, Maloney A, Hoke F, Dahl JB, Rowbotham MC. A randomized study of the effect of oral lamotrigine and hydromorphone on pain and hyperalgesia following heat/capsaicin sensitization. J Pain. 2003 Sep;4(7):400-6. doi: 10.1016/s1526-5900(03)00718-1.
citation: Scrivani S, Wallin D, Moulton EA, Cole S, Wasan AD, Lockerman L, Bajwa Z, Upadhyay J, Becerra L, Borsook D. A fMRI evaluation of lamotrigine for the treatment of trigeminal neuropathic pain: pilot study. Pain Med. 2010 Jun;11(6):920-41. doi: 10.1111/j.1526-4637.2010.00859.x. Epub 2010 May 11.