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

August 11, 2010 updated by: Universitair Ziekenhuis Brussel

Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain in Patients With Diabetic Polyneuropathy Using Proton MR Spectroscopy

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

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

  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Moens Maarten

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

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

September 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 11, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vubmtmoensLIIRA

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.

Clinical Trials on Pain

Clinical Trials on MR Spectroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe