Structural and Functional Brain Reorganization in Neuropa... | NCT02858479

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

NCT02858479

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Last Update Posted

Sep 28, 2020Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Neuropathic Pain

Interventions

stimulation on painful area (area allodynic)
same stimulation on non-painful area
MRI scan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2013-A01791-44	Other Identifier	ANSM

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

failure to recruit

Expanded Access Info

Start Date

Mar 25, 2016Actual

Primary Completion Date

Feb 11, 2019Actual

Completion Date

Feb 11, 2019Actual

First Submitted Date

Aug 1, 2016

First Submission Date that Met QC Criteria

Aug 3, 2016

First Posted Date

Aug 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2020

Last Update Posted Date

Sep 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with pain allodynic peripheral	Other		Other: stimulation on painful area (area allodynic) Other: same stimulation on non-painful area Radiation: MRI scan
patients with pain allodynic central	Other		Other: stimulation on painful area (area allodynic) Other: same stimulation on non-painful area Radiation: MRI scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Analysis pain	Measured by visual analogue scale (0 to 10)	at baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland PEYRON, MD	CHU de SAINT-ETIENNE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de SAINT-ETIENNE		Saint-Etienne		42000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques