Clinical trial NCT01180608: Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Neuropathies
Pain
Keywords: neuropathic pain
Diabetic Polyneuropathy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Moens Maarten
First posted: 2010-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)

Eligibility 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

Primary outcomes:
measure: cerebral neurobiological effect of pregabaline as treatment for neuropathic pain
timeFrame: 1 year
Secondary outcomes:
measure: cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
citation: De Jaeger M, Goudman L, Van Schuerbeek P, De Mey J, Keymeulen B, Brouns R, Moens M. Cerebral Biochemical Effect of Pregabalin in Patients with Painful Diabetic Neuropathy: A Randomized Controlled Trial. Diabetes Ther. 2018 Aug;9(4):1591-1604. doi: 10.1007/s13300-018-0460-y. Epub 2018 Jun 27.