Functional Movement DisorderSCHEMAFNCT03717376
Movement Disorders and Early Maladaptive Schemas
An observational study of Functional Movement Disorder and Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Movement Disorder, Parkinson Disease, Dystonic Disorders
- What is being tested?
- Self-questionnaire YSQ-S3 (Young Schema Questionnaire)
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2019to 12 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed-up at Pitié-Salpêtrière hospital with functional movement disorder, parkinson's disease or distonic disorders.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Guardianship or Tutelage measure
- Psychosis
- Other neurological disorder (i.e.: brain tumor, ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specificity of Early Maladaptive Schemas in Functional Movement Disorders
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.
Read the 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.
- Being tested
- Self-questionnaire YSQ-S3 (Young Schema Questionnaire)
- Keywords
- Functional Movement Disorder, Functional Neurological Disorder, Early Maladaptive Scheme, Parkinson, Dystonia
- Medical subject headings
- Conversion Disorder, Parkinson Disease, Dystonic Disorders, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaire YSQ-S3 (Young Schema Questionnaire)Other
All participants will fill the YSQ-S3 at home and send it back to the main investigator.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Clinical Severity score on UPDRS part 3 ranges from 0 (none) to 108 (severe)
Measured: 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))
Presence of anxiety if HADS-Anxiety ≥10; Presence of depression if HADS-Depression ≥10
Measured: 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)
Assessment of the different types of childhood trauma events
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start12 Feb 2019
- Primary completion12 Feb 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Movement DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard LEVY, MD. PhD, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717376
- Sponsor's protocol ID
- NI18039J
- Acronym
- SCHEMAF
- Status last verified
- Feb 2021
- First submitted
- 15 Oct 2018
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificity of Early Maladaptive Schemas in Functional Movement Disorders
- ClinicalTrials.gov ID
- NCT03717376
- Acronym / sponsor ID
- SCHEMAF / NI18039J
- Keywords
- Functional Movement Disorder, Functional Neurological Disorder, Early Maladaptive Scheme, Parkinson, Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed-up at Pitié-Salpêtrière hospital with functional movement disorder, parkinson's disease or distonic disorders.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Guardianship or Tutelage measure
- Psychosis
- Other neurological disorder (i.e.: brain tumor, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaire YSQ-S3 (Young Schema Questionnaire)All participants will fill the YSQ-S3 at home and send it back to the main investigator. | Other | – |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
Related trials for Functional Movement Disorder
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Recruiting
Dual Tasking Training to Enhance Self-Efficacy in Individuals With Parkinson's Disease
Parkinson´s Disease
Active, not recruitingObservational study
Respiratory Functions in Parkinson's Disease
Parkinson Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard LEVY, MD. PhD principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Movement Disorder and Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.