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Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01180608
Recruitment Status : Unknown
Verified August 2010 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2010
Last Update Posted : August 12, 2010
Sponsor:
Collaborator:
Moens Maarten
Information provided by:
Universitair Ziekenhuis Brussel

Brief Summary:

Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):

The aim of our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and dominant dorsolateral prefrontal cortex (DLPC).


Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Pain Other: MR Spectroscopy Not Applicable

Detailed Description:

spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex

measurements: gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain in Patients With Diabetic Polyneuropathy Using Proton MR Spectroscopy
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin Other: MR Spectroscopy

During each MR Spectroscopy session, we will measure at regions of interest (rACC, both thalami, dominant DLPC) the levels of the following biochemical substances:

  • gamma-aminobutyric acid (GABA)
  • glutamate (Glu)
  • glutamine (Gln)
  • N-acetylaspartate (NAA)
  • Choline-containing compounds (Cho)
  • Creatine plus phophocreatine (total creatine: Cr)
  • Myo-inositiol (Ins)
  • Choline (Cho)
  • Glucose (Glc)
  • Lactate (Lac)

Placebo Comparator: placebo + pregabalin Other: MR Spectroscopy

During each MR Spectroscopy session, we will measure at regions of interest (rACC, both thalami, dominant DLPC) the levels of the following biochemical substances:

  • gamma-aminobutyric acid (GABA)
  • glutamate (Glu)
  • glutamine (Gln)
  • N-acetylaspartate (NAA)
  • Choline-containing compounds (Cho)
  • Creatine plus phophocreatine (total creatine: Cr)
  • Myo-inositiol (Ins)
  • Choline (Cho)
  • Glucose (Glc)
  • Lactate (Lac)




Primary Outcome Measures :
  1. cerebral neurobiological effect of pregabaline as treatment for neuropathic pain [ Time Frame: 1 year ]
    We will measure changes in neurotransmitter levels in the brain (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) before and after treatment with pregabaline. Specific interest in ratio GABA/Gln and GABA/Glu: relationship between inhibitory and excitatory neurotransmittors


Secondary Outcome Measures :
  1. cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline [ Time Frame: 1 year ]
    A possible dose dependent effect of treatment with Pregabalin on cerebral neurochemical changes (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) and clinical effects (pain and quality of life scales) will be evaluated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with painful DPN
  • Patient willing to provide informed consent
  • Type 1 or type 2 diabetes with HbA1c ≤ 11%
  • Stable antidiabetic medication for 30 days prior to randomization
  • Duration of painful DPN ≥ 3 months
  • Visual analogue scale (VAS) score ≥ 4

Exclusion Criteria:

  • Creatinine clearance ≤ 60mL/min
  • Presence of other clinically significant or disabling chronic pain condition
  • Active malignancy
  • Evidence of an active disruptive psychiatric disorder or other known condition that might influence the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
  • Life expectancy less than 1 year
  • Existing or planned pregnancy
  • Extreme fear for entering MRI
  • General contraindication for MRI (pacemaker, etc…)
  • Patients participating in other clinical trials
  • Age <18 years
  • Prior use of potential retinotoxins
  • Prohibited medications without proper wash-out period (>7days, depending on the type of medication):

    • medications and supplements commonly used for relief of neuropathic pain
    • antiepileptics
    • antidepressants (except for stable regiments of SSRIs for treatment of anxiety or depression)
    • NSAID

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180608


Contacts
Contact: Maarten Moens, MD 0032478884047 mtmoens@gmail.com

Locations
Belgium
UZ Brussel Not yet recruiting
Brussel, Belgium, 1090
Contact: Maarten Moens, MD         
Principal Investigator: Maarten Moens, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Moens Maarten

Responsible Party: Maarten Moens, MD, UZ Brussel
ClinicalTrials.gov Identifier: NCT01180608     History of Changes
Other Study ID Numbers: vubmtmoensLIIRA
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010

Keywords provided by Universitair Ziekenhuis Brussel:
neuropathic pain
Diabetic Polyneuropathy

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Polyneuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs