Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Information source: Pain and Analgesia Imaging and Neuroscience Group
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Facial Neuropathy
Intervention: lamotrigine: 25mg and 50mg tablets (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Pain and Analgesia Imaging and Neuroscience Group Official(s) and/or principal investigator(s):
David Borsook, M.D., Ph.D., Principal Investigator, Affiliation: Mclean Hospital
Overall contact:
Sadie Cole, B.A., Phone: 617-855-3156, Email: scole@mclean.harvard.edu
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).
Clinical Details
Official title: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: blood oxygenation level-dependent (BOLD) changes in neural pain circuitry following treatment with lamotrigine during experimentally induced pain states
Secondary outcome: subjective ratings of pain during MR scanning
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Sadie Cole, B.A., Phone: 617-855-3156, Email: scole@mclean.harvard.edu
McLean Hospital Neuroimaging Center, 115 Mill Street, Belmont, Massachusetts 02478, United States; Recruiting
Sadie Cole, B.A., Phone: 617-855-3156, Email: scole@mclean.harvard.edu
David Borsook, M.D., Ph.D., Principal Investigator
Additional Information
P.A.I.N. Group article
Related publications: 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. Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens EL. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain. 1997 Nov;73(2):223-30. 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.
Starting date: October 2005
Ending date: September 2007
Last updated: September 7, 2006
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