Back to resultsStructural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic (ALLO)
Primary Purpose
Neuropathic Pain
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
stimulation on painful area (area allodynic)
same stimulation on non-painful area
MRI scan
Sponsored by
About this trial
This is an interventional other trial for Neuropathic Pain
Eligibility 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
Sites / Locations
- CHU de SAINT-ETIENNE
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patients with pain allodynic peripheral
patients with pain allodynic central
Arm Description
Outcomes
Primary Outcome Measures
the deafferentation rate
the deafferentation rate measured with thermo-test
gray matter rate
gray matter rate measured with MRI scan
Secondary Outcome Measures
Analysis pain
Measured by visual analogue scale (0 to 10)
Full Information
NCT ID
NCT02858479
First Posted
August 1, 2016
Last Updated
September 24, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02858479
Brief 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
Acronym
ALLO
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
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
February 11, 2019 (Actual)
Study Completion Date
February 11, 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 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.
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
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with pain allodynic peripheral
Arm Type
Other
Arm Title
patients with pain allodynic central
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
stimulation on painful area (area allodynic)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
same stimulation on non-painful area
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
MRI scan
Intervention Description
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 Measure Information:
Title
the deafferentation rate
Description
the deafferentation rate measured with thermo-test
Time Frame
at baseline
Title
gray matter rate
Description
gray matter rate measured with MRI scan
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Analysis pain
Description
Measured by visual analogue scale (0 to 10)
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic
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