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Structural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic (ALLO)

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ClinicalTrials.gov Identifier: NCT02858479
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : February 1, 2019
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 reorganization of brain activity.

Previous studies in functional neuroimaging have 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 objective of this study is to understand the brain dysfunction that induces allodynic pain considering the deafferentation of each patient and possible cortical losses.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Other: stimulation on painful area (area allodynic) Other: same stimulation on non-painful area Radiation: MRI scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic
Actual Study Start Date : March 25, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
patients with pain allodynic peripheral Other: stimulation on painful area (area allodynic)

these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.

stimulations for 6 seconds


Other: same stimulation on non-painful area

these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.

stimulations for 6 seconds


Radiation: MRI scan

2 sessions for 10 minutes :

  • 11 controls stimulations for 6 s each spaced 20 s without stimulation.
  • 11 allodynic stimulations for 6 s each spaced 20 s without stimulation.

patients with pain allodynic central Other: stimulation on painful area (area allodynic)

these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.

stimulations for 6 seconds


Other: same stimulation on non-painful area

these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.

stimulations for 6 seconds


Radiation: MRI scan

2 sessions for 10 minutes :

  • 11 controls stimulations for 6 s each spaced 20 s without stimulation.
  • 11 allodynic stimulations for 6 s each spaced 20 s without stimulation.




Primary Outcome Measures :
  1. the deafferentation rate [ Time Frame: at baseline ]
    the deafferentation rate measured with thermo-test

  2. gray matter rate. [ Time Frame: at baseline ]
    gray matter rate measured with MRI scan


Secondary Outcome Measures :
  1. pain [ Time Frame: at baseline ]
    pain measured by visual analogue scale (0 to 10)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • with neuropathic pain
  • in the case of central lesions, the lesion must be unique and small
  • treatment not stable opioid for one week
  • consent signed

Exclusion Criteria:

  • severe psychiatric history
  • presence of an evolutive lesion, expansive, cancerous or tumorous underlying
  • patient needing of opioid therapy
  • contraindication at 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): NCT02858479


Contacts
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Contact: Roland PEYRON, MD (0)477127805 ext +33 roland.peyron@chu-st-etienne.fr
Contact: Carine LABRUYERE, CRA (0)477120469 ext +33 carine.labruyere@chu-st-etienne.fr

Locations
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France
CHU de SAINT-ETIENNE Recruiting
Saint-etienne, France, 42000
Contact: Roland PEYRON, MD    (0)477127805 ext +33    roland.peyron@chu-st-etienne.fr   
Contact: Carine LABRUYERE, CRA    (0)477120469 ext +33    carine.labruyere@chu-st-etienne.fr   
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: NCT02858479     History of Changes
Other Study ID Numbers: 1308174
2013-A01791-44 ( Other Identifier: ANSM )
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
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
Atrophy
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms