Functional Neurological Symptom DisorderPOSiFNCT05003557
Prognostic Outcome Score in Functional Neurological Disorders
An observational study of Functional Neurological Symptom Disorder, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neurological Symptom Disorder
- What is being tested?
- Questionnaire administration
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2022to 1 Oct 2022
- 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 hospitalized in neurology ward from 2012 to 2015 and presenting with FND
Who may be able to join
- 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
Who cannot join
- Patient under legal protection
- Inability to complete a self-questionnaire
- Minor subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score
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.
Read more
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.
- Conditions
- Functional Neurological Symptom Disorder
- Being tested
- Questionnaire administration
- Keywords
- psychogenic
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
3 different questionnaires are going to be administered to each participant,
- concerning the current health situation
- the SF 36
- the IPQ-R questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evolution according the Clinical Global Impression scale
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)
Measured: continuously through study completion, an average of 1 year
Secondary outcomes (2)
Quality of life of each patient
using the 36-Item Short Form Survey (SF-36) Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.All items are scored so that a high score defines a more favorable health state.
Measured: continuously through study completion, an average of 1 year
Illness perception as reported by each patient
Using the Revised Illness Perception Questionnaire(IPQ-R)
Coding:
for identity scale yes = 1; no = 0 for other items: strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5
High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.
High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.
Measured: continuously 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 posted12 Aug 2021
- Study start5 Jan 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological Symptom DisorderStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Vercueil, MD; PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003557
- Sponsor's protocol ID
- 38RC21.167
- Other IDs
- 2021-A01181-40
- Acronym
- POSiF
- Status last verified
- Feb 2023
- First submitted
- 6 Jul 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score
- ClinicalTrials.gov ID
- NCT05003557
- Acronym / sponsor ID
- POSiF / 38RC21.167
- Conditions
- Functional Neurological Symptom Disorder
- Keywords
- psychogenic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 12 Aug 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in neurology ward from 2012 to 2015 and presenting with FND
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient under legal protection
- Inability to complete a self-questionnaire
- Minor subjects
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 |
|---|---|---|
| Questionnaire administration3 different questionnaires are going to be administered to each participant, * concerning the current health situation * the SF 36 * the IPQ-R questionnaire | Other | – |
Primary outcome
Clinical evolution according the Clinical Global Impression scale
Time frame: continuously through study completion, an average of 1 year
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)
2 secondary outcomes
Quality of life of each patient
Time frame: continuously through study completion, an average of 1 year
Illness perception as reported by each patient
Time frame: continuously 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 28 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Laurent Vercueil, MD; PhD principal investigator
University Hospital, Grenoble
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 Neurological Symptom Disorder, run by University Hospital, Grenoble 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 3 inclusion and 3 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 28 Feb 2023. 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?
Clinical evolution according the Clinical Global Impression scale (time frame: continuously 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 28 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.