Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity (CONNECT)

September 24, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne

Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain.

It induces a loss of sensitivity and likely reorganization of brain activity that are causing pain and which are the subject of this study.

Previous studies in functional neuroimaging has focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally. The authors failed to assess the part of the effect of the loss of sensory afferents (deafferentation) and the basal brain function.

Indeed, the operation without any sensory stimulation is not known yet is the initial level of activity which is the benchmark for studying brain function during stimulation. The objective of this study is to understand what are the cortical systems of allodynic dysfunctional in patients compared with controls at baseline.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for patients :

  • major
  • with nervous pain : chronic or peripheric
  • treatment not stable opioid since one week
  • signed consent

Inclusion Criteria for witnesses :

  • major
  • without chronic pain
  • signed consent

Exclusion Criteria for 2 groups :

  • severe psychiatric history
  • presence of an active nervous lesion
  • subject with morphine treatment
  • contraindication to MRI scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: peripheric nervous lesion
MRI scan
Radiation: MRI scan
EXPERIMENTAL: medullar or encephalic lesion
MRI scan
Radiation: MRI scan
OTHER: control group
MRI scan
Radiation: MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebral blood flow
Time Frame: at baseline
quantified with MRI scan
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of grey matter
Time Frame: at baseline
difference between groups
at baseline
structure of the networks
Time Frame: at baseline

Determine if structure of the networks is different between patients and controls.

Measured with MRI scan.
at baseline
connection of the networks
Time Frame: at baseline

Determine if connection of the networks is different between patients and controls.

Measured with MRI scan.
at baseline
cortical loss
Time Frame: at baseline
Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2016

Primary Completion (ACTUAL)

March 22, 2019

Study Completion (ACTUAL)

March 22, 2019

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (ESTIMATE)

August 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308144
  • 2013-A01440-45 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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