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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01180608
• Other study ID #: vubmtmoensLIIRA
• Status: Not yet recruiting
• Phase: N/A
• First received: August 10, 2010
• Last updated: August 11, 2010
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2010
• Source: Universitair Ziekenhuis Brussel
• Contact: Maarten Moens, MD
• Phone: 0032478884047
• Email: mtmoens[@]gmail.com
• Is FDA regulated: No
• Health authority: Belgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Pain

Intervention

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)

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral neurobiological effect of pregabaline as treatment for neuropathic pain	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	No
Secondary	cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline	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	No