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Functional Neurological Disorders in Patients Admitted in Stroke Units (NEUROFON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04662372
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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Brief Summary:
Functional neurological disorders are an important subgroup of patients with stroke mimics admitted to stroke unit.Their clinical profile and outcome are poorly known. The goal of this study is to describe the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.

Condition or disease Intervention/treatment
Functional Neurological Disorders Other: Description

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Neurological Disorders in Patients Admitted in Stroke Units: Clinical Profile et and 6 Months Follow-up
Actual Study Start Date : March 5, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients
Patients
 Other: Description
description of the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.


Outcome Measures
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Primary Outcome Measures :
  1. Patient characteristics [ Time Frame: 3 months ]
    Cognitive/behavioural characteristics of patients assessed for stroke using the National Institute of Health Stroke Score ranging from 0 to 42 (0: no stroke; 1-4: minor stroke; 5-15: moderate stroke; moderate to severe stroke; 21-42: severe stroke)


Secondary Outcome Measures :
  1. symptoms of patients [ Time Frame: 3 and 6 months ]
    Description of symptoms at 3 and 6 months after transition in stroke unit


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted in stroke unit for a neurological deficit, without evidence of neurovascular or othe neurological disease
Criteria

Inclusion Criteria:

  • Age over 18 years old
  • Patients admitted in stroke unit for a neurological deficit, without evidence of neurovascular or othe neurological disease.
  • NIHSS ≥ 1 at time of admission
  • Informed and consent patient to study
  • Health insured

Exclusion Criteria:

  • Patient receiving legal protection
  • Pregnant or breastfeeding woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662372


Contacts
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Contact: Amelie Yavchitz, PhD 01 48 03 64 54 ayavchitz@for.paris
Contact: Sarah BENISTY 01 48 03 67 14 sbenisty@for.paris

Locations
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France
Hopital Fondation Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Amélie Yavchitz    01 48 03 64 54    ayavchitz@for.paris   
Contact: Sarah Benisty, MD    01 48 03 67 14    sbenisty@for.paris   
Principal Investigator: Sarah Benisty, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04662372    
Other Study ID Numbers: SBY_2020_1
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Diseases