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

Not Applicable

• Conditions: Diabetic Neuropathies; Pain
• Interventions: Other: MR Spectroscopy

• Registration Number: NCT01180608
• Lead Sponsor: 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).

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 Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-11
• Last Update Submitted: 2010-08-11
• Study First Posted: 2010-08-12
• Last Update Posted: 2010-08-12
• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	MR Spectroscopy	-
placebo + pregabalin	MR Spectroscopy	-

Primary Outcome Measures

Name	Time	Method
cerebral neurobiological effect of pregabaline as treatment for neuropathic pain	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

Name	Time	Method
cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline	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

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Belgium