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

NCT02858466 | Terminated

• 2 other identifiers: 13081442013-A01440-45
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• cerebral blood flow

  quantified with MRI scan

  at baseline

Secondary Outcomes (4)

• rate of grey matter

  at baseline

• structure of the networks

  at baseline

• connection of the networks

  at baseline

• cortical loss

  at baseline

Study Arms (3)

peripheric nervous lesion

EXPERIMENTAL

MRI scan

Radiation: MRI scan

medullar or encephalic lesion

EXPERIMENTAL

MRI scan

Radiation: MRI scan

control group

OTHER

MRI scan

Radiation: MRI scan

Interventions

MRI scan RADIATION

control group; medullar or encephalic lesion; peripheric nervous lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• major
• with nervous pain : chronic or peripheric
• treatment not stable opioid since one week
• signed consent
• major
• without chronic pain
• signed consent

You may not qualify if:

• severe psychiatric history
• presence of an active nervous lesion
• subject with morphine treatment
• contraindication to MRI scan

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Roland PEYRON, MD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 8, 2016
• Study Start: March 25, 2016
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)