NCT02858479

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

August 1, 2016

Last Update Submit

September 24, 2020

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

  • the deafferentation rate

    the deafferentation rate measured with thermo-test

    at baseline

  • gray matter rate

    gray matter rate measured with MRI scan

    at baseline

Secondary Outcomes (1)

  • Analysis pain

    at baseline

Study Arms (2)

patients with pain allodynic peripheral

OTHER
Other: stimulation on painful area (area allodynic)Other: same stimulation on non-painful areaRadiation: MRI scan

patients with pain allodynic central

OTHER
Other: stimulation on painful area (area allodynic)Other: same stimulation on non-painful areaRadiation: MRI scan

Interventions

stimulation on painful area (area allodynic)OTHER

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

patients with pain allodynic centralpatients with pain allodynic peripheral
same stimulation on non-painful areaOTHER

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

patients with pain allodynic centralpatients with pain allodynic peripheral
MRI scanRADIATION

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.

patients with pain allodynic centralpatients with pain allodynic peripheral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe psychiatric history
  • presence of an evolutive lesion, expansive, cancerous or tumorous underlying
  • patient needing of opioid therapy
  • contraindication at MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative 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

August 1, 2016

First Posted

August 8, 2016

Study Start

March 25, 2016

Primary Completion

February 11, 2019

Study Completion

February 11, 2019

Last Updated

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)