NCT03717376

Brief Summary

Functional neurological disorders (FND) are neurological symptoms that cannot be explained by a lesion or related to an identified dysfunction of the central nervous system. FND are under-diagnosed, although common and highly disabling. Childhood trauma events are found in 30% to 80% of FND patients, and are more common in people with functional neurological disorder than in healthy controls and patient controls. Overall, risks factors, perpetuating factors and maintaining factors have been described in FND, although none of the studies have analysed the prevalence of Early Maladaptive Schemas (EMS) in these patients. EMS, as measured with the Young Schema Questionnaire (YSQ), are proposed to underlie a variety of mental health problems, in particular Personality Disorders. We hypothesize that some of these early maladaptive schemas may participate in the psychopathology and severity of FND. The main outcome of this study is to assess the prevalence of early maladaptive schemas in patients presenting with Functional Movement Disorders in comparison to patients presenting with Parkinson's Disease or Organic Dystonia. The secondary outcomes are to further analyse the underlying relation of these early maladaptive schemas and (i) the severity of the motor symptoms, (ii) anxiety and/or depression, (iii) the occurrence of childhood trauma events in our participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

January 31, 2022

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

October 15, 2018

Last Update Submit

January 28, 2022

Conditions

Keywords

Functional Movement DisorderFunctional Neurological DisorderEarly Maladaptive SchemeParkinsonDystonia

Outcome Measures

Primary Outcomes (1)

  • Assessment of the prevalence of early maladaptive schemas in patients with Functional Movement Disorders versus patients with Parkinson's Disease or Dystonic Disorders

    Score ≥16 in each schema on the Young Schema Questionnaire-S3 (YSQ-S3) is considered as pathological

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Correlation between the YSQ-S3 scores and the severity of motor symptoms (score from the Unified Parkinson's Disease Rating Scale (UPDRS) part 3)

    Through study completion, an average of 1 year

  • Correlation between the YSQ-S3 scores and anxiety/depression symptoms (screened with the Hospital Anxiety and Depression Scale (HADS) together with the Mini International Neuropsychiatric Interview (MINI))

    Through study completion, an average of 1 year

  • Correlation between the YSQ-S3 scores and self-reported childhood traumatic events (assessed with the Composite International Diagnosis Interview (CIDI) questionnaire)

    Through study completion, an average of 1 year

Interventions

All participants will fill the YSQ-S3 at home and send it back to the main investigator.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed-up at Pitié-Salpêtrière hospital with functional movement disorder, parkinson's disease or distonic disorders.

You may qualify if:

  • Age ≥ 18 years-old
  • Being diagnosed with Parkinson's Disease (United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria) or with Functional Movement Disorder (Gupta \& Lang criteria) or with Dystonia (criteria from Obeso et al. Mov Dis 2013)
  • Being previously included in the research protocol untitled " Retentissement des mouvements anormaux "
  • Patient informed and having given their non-opposition
  • Written and oral comprehension of French

You may not qualify if:

  • Pregnancy
  • Guardianship or Tutelage measure
  • Psychosis
  • Other neurological disorder (i.e.: brain tumor, ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP - Pitié-Salpêtrière hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Conversion DisorderParkinson DiseaseDystonic DisordersDystonia

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard LEVY, MD. PhD

    Assistance Publique Hoptiaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 24, 2018

Study Start

February 12, 2019

Primary Completion

February 12, 2019

Study Completion

February 12, 2020

Last Updated

January 31, 2022

Record last verified: 2021-02

Locations