Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

December 6, 2018 updated by: David Borsook, M.D., Ph.D., Pain and Analgesia Imaging and Neuroscience Group
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital Neuroimaging Center, 115 Mill Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lamotrigine to Placebo 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.
Drug: Lamotrigine
: 25mg and 50mg tablets
Other Names:
  • LAM
  • LAMO
Active Comparator: Placebo to Lamotrigine Crossover
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.
Drug: Placebo (for Lamotrigine)
Sugar pill manufactured to mimic Lamotrigine tablets
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 10 during scanning session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 10 (during the scan)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pain and Analgesia Imaging and Neuroscience Group

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: David Borsook, M.D., Ph.D., McLean Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Facial Neuropathy/lamotrigine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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