Functionnal Neurological DisorderProcess-TNFNCT06691295
Exploring Transdiagnostic Psychological Processes in Functional Neurological Disorder
An observational study of Functionnal Neurological Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Functional neurological disorder (FND) is a little-known borderline disorder between psychiatry and neurology, which is benefiting from renewed research. Characterized by neurological symptoms in the absence of lesion damage corresponding to the symptom, the disorder is thought to be due to functional impairment of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functionnal Neurological Disorder
- What is being tested?
- Questionnaires
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 31 Jul 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort is selected from patients in the PULS-TNF program, which takes in all FND patients from the university hospital of Lyon or referred by other physicians.
Who may be able to join
- Subjects diagnosed with FND by a neurologist ("Conversion disorder (disorder with functional neurological symptomatology" in DSM5)) from neurological report
- Subject presenting one of the main phenotypes, i.e. 1. sensitivo-motor, 2. seizure / malaise (CNEP) as indicated by neurological report
- Prior to any psychological, psychiatric or rehabilitative treatment for this TNF
- Subject able to receive information and not to object to the use of his/her data for research purposes
Who cannot join
- Subjects with symptoms corresponding to a pure pain or cognitive phenotype - patient's medical record
- Subject with cognitive disorders - Moca score < 18
- Subjects with diagnosed psychiatric comorbidities according to psychiatric CR + HADS scores A > 11 and D > 11
- Subjects with neurological comorbidities - according to neurologist's CR
Trial locations and contacts
1 site in 1 country.
About this study
Functional neurological disorder (FND) is a little-known borderline disorder between psychiatry and neurology, which is benefiting from renewed research. Characterized by neurological symptoms in the absence of lesion damage corresponding to the symptom, the disorder is thought to be due to functional impairment of the central nervous system (DSM5 American Psychiatric Association, 2013). Symptoms are non-congruent, discordant and inconsistent with current anatomical knowledge. Several phenotypes are listed and may be associated: among the most frequent are motor and sensory disorders and dissociative crises or seizures.
Common (Carson \& Lehn, 2016) and disabling (Gendre et al., 2019), the neurobiological and psychological mechanisms involved in NFT are becoming better understood, yet its etiology remains enigmatic (Hallett et al., 2022). Recent theoretical models consider neuropsychological constructs as central to the development and maintenance of the disorder, influenced by emotional processes (Drane et al., 2020).
Read more
With a reputation for being difficult to treat, FND is a clinical challenge, and cognitive-behavioural therapy (CBT), although advocated, shows limits of efficacy mainly due to the complexity of clinical pictures and the heterogeneity of profiles (Gutkin et al., 2021). The CBTs described for FND are not specific to the disorder, and do not appear to be developed around a general theoretical framework defining the psychological mechanisms of the disorder (Richardson et al., 2020).
Thus, there would be an interest in identifying characteristics in these patients that could guide therapeutic choices and implement a better therapeutic response (Gutkin et al., 2021). These findings, coupled with the growing interest in this complex disorder, confirm the need to deepen our knowledge of the psychological mechanisms involved in the disorder, with a view to developing and testing a specialized and flexible clinic (Aybek et al., 2020).
Given the complexity of the disorder, a transdiagnostic approach is suggested (Saxena \& Perez, 2021). The transdiagnostic processual approach (Harvey et al., 2004) proposes an innovative conceptualization of mental health problems. This model sees the human biological system as leading to psychological disorder through the disruption of initially normal psychological processes (Kinderman, 2005). These processes refer to psychological mechanisms on which the clinician can act, via validated therapeutic strategies. Transdiagnostic treatments apply the same underlying treatment principles to all mental disorders, without tailoring the protocol to specific diagnoses (Menon et al., 2017).
Considering the psychological mechanisms described as being altered in the disorder, etiological hypotheses, and literature data concerning transdiagnostic psychological processes, we raise the question of the involvement of such processes in FND. The aim of this study is to explore these processes in an FND population, with a view to refining our understanding of the psychological profile of these patients and guiding treatment.
- Conditions
- Functionnal Neurological Disorder
- Being tested
- Questionnaires
- Keywords
- Functional neurological disorder Transdiagnostic psychological processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
This study aims to explore transdiagnostic psychological processes (PP) via the administration of self-reported scales and questionnaires, in a population of newly diagnosed FND patients, prior to any therapeutic management.
The main objective is to describe the psychometric properties (scores on tools measuring psychological processes) of NFT patients (presenting the main phenotypes; sensitivo-motor; and seizures and discomfort).
| Study group | Role | What they receive |
|---|---|---|
| Patients with functional neurological disorders. | This study focuses on adult subjects with newly diagnosed functional neurological disorders (less than 5 years old) and prior to therapeutic management. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncertainty Intolerance Scale - II
Scores on the Uncertainty Intolerance Scale - II to assess intolerance of uncertainty.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Metacognitive Belief Questionnaire - MCQ-30
Scores on the Metacognitive Belief Questionnaire - MCQ-30 to assess metacognitive beliefs.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Ruminations Scale - Mini-CERTS
Scores on the Ruminations Scale - Mini-CERTS to assess ruminative thinking patterns.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Experiential Avoidance Questionnaire - MEAQ-short
Scores on the Experiential Avoidance Questionnaire - MEAQ-short to assess experiential avoidance.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Personalized Psychological Flexibility Index - PPFI
Scores on the Personalized Psychological Flexibility Index - PPFI to assess psychological flexibility.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Emotional Regulation Scale - DERS-F
Scores on the Emotional Regulation Scale - DERS-F to assess emotional regulation.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Somatoform Dissociation Questionnaire - SDQ-20
Scores on the Somatoform Dissociation Questionnaire - SDQ-20 to assess somatoform dissociation.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Short Form Health Survey - SF-36
Scores on the Short Form Health Survey - SF-36 to assess general health and quality of life.
Measured: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 May 2024
- Primary completion7 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functionnal Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOUAMMARI Annablle, Principal investigator, Neurologie inflammatoire Hôpital P. Wertheimer/GHE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691295
- Sponsor's protocol ID
- 23-5173
- Acronym
- Process-TNF
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 15 Nov 2024
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Transdiagnostic Psychological Processes in Functional Neurological Disorder
- ClinicalTrials.gov ID
- NCT06691295
- Acronym / sponsor ID
- Process-TNF / 23-5173
- Conditions
- Functionnal Neurological Disorder
- Keywords
- Functional neurological disorder Transdiagnostic psychological processes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 Nov 2024 (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 disorder (FND) is a little-known borderline disorder between psychiatry and neurology, which is benefiting from renewed research. Characterized by neurological symptoms in the absence of lesion damage corresponding to the symptom, the disorder is thought to be due to functional impairment of the central nervous system (DSM5 American Psychiatric Association, 2013). Symptoms are non-congruent, discordant and inconsistent with current anatomical knowledge. Several phenotypes are listed and may be associated: among the most frequent are motor and sensory disorders and dissociative crises or seizures.
Common (Carson \& Lehn, 2016) and disabling (Gendre et al., 2019), the neurobiological and psychological mechanisms involved in NFT are becoming better understood, yet its etiology remains enigmatic (Hallett et al., 2022). Recent theoretical models consider neuropsychological constructs as central to the development and maintenance of the disorder, influenced by emotional processes (Drane et al., 2020).
With a reputation for being difficult to treat, FND is a clinical challenge, and cognitive-behavioural therapy (CBT), although advocated, shows limits of efficacy mainly due to the complexity of clinical pictures and the heterogeneity of profiles (Gutkin et al., 2021). The CBTs described for FND are not specific to the disorder, and do not appear to be developed around a general theoretical framework defining the psychological mechanisms of the disorder (Richardson et al., 2020).
Thus, there would be an interest in identifying characteristics in these patients that could guide therapeutic choices and implement a better therapeutic response (Gutkin et al., 2021). These findings, coupled with the growing interest in this complex disorder, confirm the need to deepen our knowledge of the psychological mechanisms involved in the disorder, with a view to developing and testing a specialized and flexible clinic (Aybek et al., 2020).
Given the complexity of the disorder, a transdiagnostic approach is suggested (Saxena \& Perez, 2021). The transdiagnostic processual approach (Harvey et al., 2004) proposes an innovative conceptualization of mental health problems. This model sees the human biological system as leading to psychological disorder through the disruption of initially normal psychological processes (Kinderman, 2005). These processes refer to psychological mechanisms on which the clinician can act, via validated therapeutic strategies. Transdiagnostic treatments apply the same underlying treatment principles to all mental disorders, without tailoring the protocol to specific diagnoses (Menon et al., 2017).
Considering the psychological mechanisms described as being altered in the disorder, etiological hypotheses, and literature data concerning transdiagnostic psychological processes, we raise the question of the involvement of such processes in FND. The aim of this study is to explore these processes in an FND population, with a view to refining our understanding of the psychological profile of these patients and guiding treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with functional neurological disorders. | – | Other: QuestionnairesThis study focuses on adult subjects with newly diagnosed functional neurological disorders (less than 5 years old) and prior to therapeutic management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort is selected from patients in the PULS-TNF program, which takes in all FND patients from the university hospital of Lyon or referred by other physicians.
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| QuestionnairesThis study aims to explore transdiagnostic psychological processes (PP) via the administration of self-reported scales and questionnaires, in a population of newly diagnosed FND patients, prior to any therapeutic management. The main objective is to describe the psychometric properties (scores on tools measuring psychological processes) of NFT patients (presenting the main phenotypes; sensitivo-motor; and seizures and discomfort). | Other | Patients with functional neurological disorders. |
Primary outcome
Uncertainty Intolerance Scale - II
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Uncertainty Intolerance Scale - II to assess intolerance of uncertainty.
Metacognitive Belief Questionnaire - MCQ-30
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Metacognitive Belief Questionnaire - MCQ-30 to assess metacognitive beliefs.
Ruminations Scale - Mini-CERTS
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Ruminations Scale - Mini-CERTS to assess ruminative thinking patterns.
Experiential Avoidance Questionnaire - MEAQ-short
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Experiential Avoidance Questionnaire - MEAQ-short to assess experiential avoidance.
Personalized Psychological Flexibility Index - PPFI
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Personalized Psychological Flexibility Index - PPFI to assess psychological flexibility.
Emotional Regulation Scale - DERS-F
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Emotional Regulation Scale - DERS-F to assess emotional regulation.
Somatoform Dissociation Questionnaire - SDQ-20
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Somatoform Dissociation Questionnaire - SDQ-20 to assess somatoform dissociation.
Short Form Health Survey - SF-36
Time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
Scores on the Short Form Health Survey - SF-36 to assess general health and quality of life.
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 15 Nov 2024.
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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.
BOUAMMARI Annablle principal investigator
Neurologie inflammatoire Hôpital P. Wertheimer/GHE
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 Functionnal Neurological Disorder, run by Hospices Civils de Lyon 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 4 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 15 Nov 2024. 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?
Uncertainty Intolerance Scale - II (time frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.). The study lists 8 primary outcomes in all. 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 15 Nov 2024.