Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Facial Neuropathy Clinical Trial

Official title:

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243152
• Other study ID #: Facial Neuropathy/lamotrigine
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: July 2008

Study information

• Verified date: December 2018
• Source: Pain and Analgesia Imaging and Neuroscience Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Nerve Diseases
• Facial Neuropathy
• Facial Pain
• Facies

Intervention

Drug:
• Lamotrigine
: 25mg and 50mg tablets
• Placebo (for Lamotrigine)
Sugar pill manufactured to mimic Lamotrigine tablets

Locations

Country	Name	City	State
United States	McLean Hospital Neuroimaging Center, 115 Mill Street	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Pain and Analgesia Imaging and Neuroscience Group	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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.152 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States	fMRI scans acquired Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness fMRI scans acquired Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** fMRI scans acquired Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** Cortical, subcortical, and brain stem sensory regions Z-scores Increase or decrease in activation as affected by the drug	Week 10 during scanning session
Secondary	Subjective Ratings of Pain During Magnetic Resonance Scanning	Quantitative Sensory Testing (QST); Stimuli Type: Heat, Cold, Brush Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness; Ratings on a likert scale of 0-10 with 0 being defined as no pain and 10 being defined as worst possible pain	week 10 (during the scan)

External Links

•   P.A.I.N. Group article