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

Primary Purpose

Neuropathic Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI scan
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

peripheric nervous lesion

medullar or encephalic lesion

control group

Arm Description

MRI scan

MRI scan

MRI scan

Outcomes

Primary Outcome Measures

cerebral blood flow
quantified with MRI scan

Secondary Outcome Measures

rate of grey matter
difference between groups
structure of the networks
Determine if structure of the networks is different between patients and controls. Measured with MRI scan.
connection of the networks
Determine if connection of the networks is different between patients and controls. Measured with MRI scan.
cortical loss
Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.

Full Information

First Posted
July 25, 2016
Last Updated
September 24, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02858466
Brief Title
Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Acronym
CONNECT
Official Title
Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
failure to recruit
Study Start Date
March 25, 2016 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
peripheric nervous lesion
Arm Type
Experimental
Arm Description
MRI scan
Arm Title
medullar or encephalic lesion
Arm Type
Experimental
Arm Description
MRI scan
Arm Title
control group
Arm Type
Other
Arm Description
MRI scan
Intervention Type
Radiation
Intervention Name(s)
MRI scan
Primary Outcome Measure Information:
Title
cerebral blood flow
Description
quantified with MRI scan
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
rate of grey matter
Description
difference between groups
Time Frame
at baseline
Title
structure of the networks
Description
Determine if structure of the networks is different between patients and controls. Measured with MRI scan.
Time Frame
at baseline
Title
connection of the networks
Description
Determine if connection of the networks is different between patients and controls. Measured with MRI scan.
Time Frame
at baseline
Title
cortical loss
Description
Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland PEYRON, MD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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