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

Neuropathic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02858479
• Other study ID #: 1308174
• Secondary ID: 2013-A01791-44
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrophy
• Neuralgia
• Neuropathic Pain

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