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Completed

NCT Number: NCT00243152

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

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).

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Key information

Conditions

Facial Neuropathy Cranial Nerve Diseases Disease Attributes Facial Nerve Diseases Facies Mouth Diseases Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital Neuroimaging Center, 115 Mill Street

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine

Drug

: 25mg and 50mg tablets

Other names: LAMO, LAM

Placebo (for Lamotrigine)

Drug

Sugar pill manufactured to mimic Lamotrigine tablets

Other names: Placebo

Primary outcomes

  1. Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States

    Time frame: Week 10 during scanning session

    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

Secondary outcomes

  1. Subjective Ratings of Pain During Magnetic Resonance Scanning

    Time frame: week 10 (during the scan)

    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

Sponsors and collaborators

Lead sponsor

Pain and Analgesia Imaging and Neuroscience Group

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 21, 2005
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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