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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

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.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Radiation: MRI scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Actual Study Start Date : March 25, 2016
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

Arm Intervention/treatment
Experimental: peripheric nervous lesion
MRI scan
Radiation: MRI scan
Experimental: medullar or encephalic lesion
MRI scan
Radiation: MRI scan
control group
MRI scan
Radiation: MRI scan



Primary Outcome Measures :
  1. cerebral blood flow [ Time Frame: at baseline ]
    quantified with MRI scan


Secondary Outcome Measures :
  1. rate of grey matter [ Time Frame: at baseline ]
    difference between groups

  2. structure of the networks [ Time Frame: at baseline ]

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

    Measured with MRI scan.


  3. connection of the networks [ Time Frame: at baseline ]

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

    Measured with MRI scan.


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858466


Locations
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France
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Roland PEYRON, MD CHU de SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02858466    
Other Study ID Numbers: 1308144
2013-A01440-45 ( Other Identifier: ANSM )
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations