A Cohort of Acute, Ischemic and Rare Neuropathies (CAIRN)

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Neuropathies are defined as the clinical, electrical, biological and histological manifestations of peripheral neuron damage. They represent a heterogeneous group of disorders and are responsible for disabling sensory and motor disorders. Their diagnosis is based on a set of clinical arguments confirmed by the electromyogram. This allows to specify the site of the damage, its severity, and to follow the evolution of the disease.

To date, the diagnosis of peripheral nerve injury secondary to occlusion of arterial trunks is rarely evoked; its clinical, electromyographic and prognostic characteristics are poorly known. Indeed, the rare cases reported in the literature are from vascular specialties, with little data on neurological symptoms, neurophysiological diagnostic elements and prognosis.

However, these unrecognized and underdiagnosed neuropathies are sometimes indicative of severe vascular damage for which urgent management is necessary. Neurological symptoms should then be treated as warning signs and the correct recognition of the early ischemic vascular etiology may lead to an optimized medical management.

The objectives of this study will be to describe the clinical presentation of these neuropathies, to discuss their electrophysiological diagnostic characteristics, to compare the demographic data with those from the literature, and to evaluate the functional prognosis of these attacks. A better knowledge of this rare etiology of neuropathy would allow to better inform the patients and to optimize the diagnostic and therapeutic management.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient hospitalized or seen in neurophysiological consultation/exploration in the Neurology Department within the Groupe Hospitalier Paris Saint-Joseph, with Diagnosis of acute or subacute peripheral nerve ischemia

Description

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Patient hospitalized or seen in neurophysiological consultation/exploration in the Neurology Department within the Groupe Hospitalier Paris Saint-Joseph
  • Diagnosis of acute or subacute peripheral nerve ischemia
  • French speaking patient

Exclusion Criteria:

  • Patient with impaired comprehension making it impossible to understand the protocol
  • Patient under guardianship or curatorship
  • Patient under court protection
  • Patient deprived of liberty
  • Patient or relative who objects to the use of his/her data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of patients according to their neurophysiological impairment
Time Frame: Month 1
This outcome corresponds to the description of patient demographics and cardiovascular history/risk factors.
Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic factors for functional recovery
Time Frame: Month 1
This outcome corresponds to the the prognosis of the disease (return to the previous state/persistence of a partial deficit/persistence of symptoms) and the time to improvement.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Vincent Roubeau, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Actual)

September 25, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIRN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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