Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity

Neuropathic Pain Clinical Trial

— CONNECT  

Official title:

Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02858466
• Other study ID #: 1308144
• Secondary ID: 2013-A01440-45
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2016
• Est. completion date: March 22, 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Radiation:
• MRI scan

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	cerebral blood flow	quantified with MRI scan	at baseline
Secondary	rate of grey matter	difference between groups	at baseline
Secondary	structure of the networks	Determine if structure of the networks is different between patients and controls.; Measured with MRI scan.	at baseline
Secondary	connection of the networks	Determine if connection of the networks is different between patients and controls.; Measured with MRI scan.	at baseline
Secondary	cortical loss	Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.	at baseline