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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Universitair Ziekenhuis Brussel.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Moens Maarten
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01180608
First received: August 10, 2010
Last updated: August 11, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention
Diabetic Neuropathies
Pain
 Other: MR Spectroscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • cerebral neurobiological effect of pregabaline as treatment for neuropathic pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Maarten Moens, MD, UZ Brussel
ClinicalTrials.gov Identifier: NCT01180608     History of Changes
Other Study ID Numbers: vubmtmoensLIIRA
Study First Received: August 10, 2010
Last Updated: August 11, 2010
Health Authority: Belgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten

Keywords provided by Universitair Ziekenhuis Brussel:
neuropathic pain
Diabetic Polyneuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
 Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013