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

NCT ID: NCT02858479

Last Updated: 2020-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-25

Study Completion Date

2019-02-11

Brief Summary

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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

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients with pain allodynic peripheral

Group Type OTHER

stimulation on painful area (area allodynic)

Intervention Type 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

same stimulation on non-painful area

Intervention Type 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

MRI scan

Intervention Type RADIATION

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 central

Group Type OTHER

stimulation on painful area (area allodynic)

Intervention Type 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

same stimulation on non-painful area

Intervention Type 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

MRI scan

Intervention Type RADIATION

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.

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland PEYRON, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01791-44

Identifier Type: OTHER

Identifier Source: secondary_id

1308174

Identifier Type: -

Identifier Source: org_study_id

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