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Movement Disorders and Early Maladaptive Schemas (SCHEMAF)

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: NCT03717376
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Functional Movement Disorder Parkinson Disease Dystonic Disorders Other: Self-questionnaire YSQ-S3 (Young Schema Questionnaire)

Detailed Description:

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. Functional Movement Disorders are a sub-category of FND, affecting the voluntary motor command. 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, and some team research as Brown R. and al. have attempted to include it in psychopathological models such as the Integrative Conceptual Model in 2004. Nonetheless, 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. Jeffrey Young has developed this concept in the 90's, through the so called "Schema Therapy". EMS are proposed as the core and main target for treatment of personality disorders and long-standing characterological problems. The current definition of an EMS is "a broad, pervasive theme or pattern, comprised of memories, emotions, cognitions, and bodily sensations, regarding oneself and one's relationships with others, developed during childhood or adolescence, elaborated throughout one's lifetime and dysfunctional to a significant degree". It has been studied in various conditions such as obesity, personality disorders, post-traumatic stress disorder, or obsessive-compulsive disorder, finding some EMS specificity in patients presenting with these conditions. In our study, 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.

In order to reach these objectives, we aim to include 77 patients from which 30 patients with Functional Movement Disorder, 28 patients with Parkinson's disease, 19 patients with organic dystonia.

All eligible participants who have accepted to participate in the study will fill the YSQ-S3 (Short Form, French Version, validated and reliable instrument in clinical and research settings).The YSQ-S3 is a self-questionnaire which uses a Likert-type ranking, whereby 1 means "completely untrue of me" and 6 means "describes me perfectly". Similarly, questions range from life experiences to present feelings about certain situations. It consists of 90 self-report items, measuring all of the 18 EMS, aiming to describe one's functioning schemas over the past year.

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Study Type : Observational
Estimated Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specificity of Early Maladaptive Schemas in Functional Movement Disorders
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : February 12, 2020
Estimated Study Completion Date : February 12, 2020



Intervention Details:
  • Other: Self-questionnaire YSQ-S3 (Young Schema Questionnaire)
    All participants will fill the YSQ-S3 at home and send it back to the main investigator.


Primary Outcome Measures :
  1. Assessment of the prevalence of early maladaptive schemas in patients with Functional Movement Disorders versus patients with Parkinson's Disease or Dystonic Disorders [ Time Frame: Through study completion, an average of 1 year ]
    Score ≥16 in each schema on the Young Schema Questionnaire-S3 (YSQ-S3) is considered as pathological


Secondary Outcome Measures :
  1. Correlation between the YSQ-S3 scores and the severity of motor symptoms (score from the Unified Parkinson's Disease Rating Scale (UPDRS) part 3) [ Time Frame: Through study completion, an average of 1 year ]
    Clinical Severity score on UPDRS part 3 ranges from 0 (none) to 108 (severe)

  2. 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)) [ Time Frame: Through study completion, an average of 1 year ]
    Presence of anxiety if HADS-Anxiety ≥10; Presence of depression if HADS-Depression ≥10

  3. Correlation between the YSQ-S3 scores and self-reported childhood traumatic events (assessed with the Composite International Diagnosis Interview (CIDI) questionnaire) [ Time Frame: Through study completion, an average of 1 year ]
    Assessment of the different types of childhood trauma events



Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients followed-up at Pitié-Salpêtrière hospital with functional movement disorder, parkinson's disease or distonic disorders.
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years-old
  2. 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)
  3. Being previously included in the research protocol untitled " Retentissement des mouvements anormaux "
  4. Patient informed and having given their non-opposition
  5. Written and oral comprehension of French

Exclusion Criteria:

  1. Pregnancy
  2. Guardianship or Tutelage measure
  3. Psychosis
  4. Other neurological disorder (i.e.: brain tumor, ...)

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): NCT03717376


Contacts
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Contact: Richard LEVY, MD. PhD 33 (0)1 42 16 17 55 richard.levy@aphp.fr
Contact: Guilhem CARLE, MD, MSc 33 (0)1 42 16 17 62 guilhem.carle@icm-institute.org

Locations
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France
APHP - Pitié-Salpêtrière hospital Recruiting
Paris, France, 75013
Contact: Richard LEVY, MD. PhD       richard.levy@aphp.fr   
Contact: Guilhem CARLE, MD, MSc       guilhem.carle@icm-institute.org   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Richard LEVY, MD. PhD Assistance Publique Hoptiaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03717376    
Other Study ID Numbers: NI18039J
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Functional Movement Disorder
Functional Neurological Disorder
Early Maladaptive Scheme
Parkinson
Dystonia
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Dystonic Disorders
Dystonia
Disease
Conversion Disorder
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Somatoform Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms