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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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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).

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Detailed Description

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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)

Conditions

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Diabetic Neuropathies Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pregabalin

Group Type ACTIVE_COMPARATOR

MR Spectroscopy

Intervention Type OTHER

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 + pregabalin

Group Type PLACEBO_COMPARATOR

MR Spectroscopy

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No