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TerminatedNCT02858479ALLOUpdated Sep 28, 2020

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

An interventional study of stimulation on painful area (area allodynic) and same stimulation on non-painful area in Neuropathic Pain, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-28.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other

Why this study was terminated
failure to recruit

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2016, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Neuropathic Pain
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 41 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • severe psychiatric history
  • presence of an evolutive lesion, expansive, cancerous or tumorous underlying
  • patient needing of opioid therapy
  • contraindication at MRI scan
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Other
    patients with pain allodynic peripheral

    Other: stimulation on painful area (area allodynic) · Other: same stimulation on non-painful area · Radiation: MRI scan

  • Other
    patients with pain allodynic central

    Other: stimulation on painful area (area allodynic) · Other: same stimulation on non-painful area · Radiation: MRI scan

Interventions

  • Otherstimulation 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

  • Othersame 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

  • RadiationMRI 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.

06

What researchers measure

Primary outcomes

  1. the deafferentation rate

    the deafferentation rate measured with thermo-test

    Time frame: at baseline

  2. gray matter rate

    gray matter rate measured with MRI scan

    Time frame: at baseline

Secondary outcomes

  1. Analysis pain

    Measured by visual analogue scale (0 to 10)

    Time frame: at baseline

07

Study locations

1 site
  • CHU de SAINT-ETIENNE
    Saint-etienne, 42000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02858479
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Aug 8, 2016
Start date
Mar 25, 2016
Primary completion
Feb 11, 2019
Completion
Feb 11, 2019
Last update
Sep 28, 2020

Study contacts

Roland PEYRON, MD
principal investigator · CHU de SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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