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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02858479
Other study ID # 1308174
Secondary ID 2013-A01791-44
Status Terminated
Phase N/A
First received
Last updated
Start date March 25, 2016
Est. completion date February 11, 2019

Study information

Verified date September 2020
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 41
Est. completion date February 11, 2019
Est. primary completion date February 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
France CHU de SAINT-ETIENNE Saint-etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary the deafferentation rate the deafferentation rate measured with thermo-test at baseline
Primary gray matter rate gray matter rate measured with MRI scan at baseline
Secondary Analysis pain Measured by visual analogue scale (0 to 10) at baseline
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