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

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ClinicalTrials.gov Identifier: NCT02858466
Recruitment Status : Terminated (failure to recruit)
First Posted : August 8, 2016
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE July 25, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE March 25, 2016
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
cerebral blood flow [ Time Frame: at baseline ]
quantified with MRI scan
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • rate of grey matter [ Time Frame: at baseline ]
    difference between groups
  • structure of the networks [ Time Frame: at baseline ]
    Determine if structure of the networks is different between patients and controls. Measured with MRI scan.
  • connection of the networks [ Time Frame: at baseline ]
    Determine if connection of the networks is different between patients and controls. Measured with MRI scan.
  • cortical loss [ Time Frame: at baseline ]
    Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Official Title  ICMJE Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE Radiation: MRI scan
Study Arms  ICMJE
  • Experimental: peripheric nervous lesion
    MRI scan
    Intervention: Radiation: MRI scan
  • Experimental: medullar or encephalic lesion
    MRI scan
    Intervention: Radiation: MRI scan
  • control group
    MRI scan
    Intervention: Radiation: MRI scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 24, 2020)
68
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2016)
75
Actual Study Completion Date  ICMJE March 22, 2019
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02858466
Other Study ID Numbers  ICMJE 1308144
2013-A01440-45 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland PEYRON, MD CHU de SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP