Clinical trial NCT05003557: Prognostic Outcome Score in Functional Neurological Disorders
Official title: Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Neurological Symptom Disorder
Keywords: psychogenic
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized in neurology ward from 2012 to 2015 and presenting with FND

Brief summary: Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care.

The aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records.

The investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present.

Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.


Eligibility criteria: Inclusion Criteria:

* Male or female gender
* Hospitalization in Neurology Department A from 2012 to 2015 with a final retained diagnosis of NFT
* POS score at time of hospitalization available

Exclusion Criteria:

* Patient under legal protection
* Inability to complete a self-questionnaire
* Minor subjects

Primary outcomes:
measure: Clinical evolution according the Clinical Global Impression scale
timeFrame: continuously through study completion, an average of 1 year
Secondary outcomes:
measure: Quality of life of each patient
timeFrame: continuously through study completion, an average of 1 year
measure: Illness perception as reported by each patient
timeFrame: continuously through study completion, an average of 1 year
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Laurent Vercueil, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: