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TerminatedNCT02858466CONNECTUpdated Sep 28, 2020

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

An interventional study of MRI scan 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, including healthy volunteers. 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 Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
68
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 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.

02

Conditions studied

  • Neuropathic Pain

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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 68 is above 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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for patients :

  • major
  • with nervous pain : chronic or peripheric
  • treatment not stable opioid since one week
  • signed consent

Inclusion Criteria for witnesses :

  • major
  • without chronic pain
  • signed consent

Exclusion Criteria for 2 groups :

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

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

Study arms

  • Experimental
    peripheric nervous lesion

    MRI scan

    Radiation: MRI scan

  • Experimental
    medullar or encephalic lesion

    MRI scan

    Radiation: MRI scan

  • Other
    control group

    MRI scan

    Radiation: MRI scan

Interventions

  • RadiationMRI scan
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What researchers measure

Primary outcomes

  1. cerebral blood flow

    quantified with MRI scan

    Time frame: at baseline

Secondary outcomes

  1. rate of grey matter

    difference between groups

    Time frame: at baseline

  2. structure of the networks

    Determine if structure of the networks is different between patients and controls. Measured with MRI scan.

    Time frame: at baseline

  3. connection of the networks

    Determine if connection of the networks is different between patients and controls. Measured with MRI scan.

    Time frame: at baseline

  4. cortical loss

    Assess the cortical loss of the patient group compared to controls. Measured with MRI scan.

    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
NCT02858466
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Aug 8, 2016
Start date
Mar 25, 2016
Primary completion
Mar 22, 2019
Completion
Mar 22, 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 ↗

Not currently enrolling

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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