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

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Diabetic Neuropathies; Pain

Treatments: Other: MR Spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01180608

vubmtmoensLIIRA

Details and patient eligibility

About

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).

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Treatment:

Other: MR Spectroscopy

placebo + pregabalin

Placebo Comparator group

Treatment:

Other: MR Spectroscopy