Dysexecutive SyndromeSDS2NCT05017051
Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
An observational study of Dysexecutive Syndrome, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysexecutive Syndrome
- What is being tested?
- Chocolate cake, Lego model and Measurement of sensorimotor abilities
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 442 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2021to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is composed of 2 groups: * a group of patients with dysexecutive syndrome * a group of healthy subjects
Who may be able to join
- Patients with a dysexecutive syndrome OR healthy subjects
- Over 18 years-old
Who cannot join
- Patients
- Psychiatric pathology (except for Post-Traumatic Stress Disorder)
- Pregnant or breastfeeding woman
- Healthy subjects
- Neurologic or psychiatric pathology
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital d'Instruction des Armées Percy
Clamart, 92140
Flavie BOMPAIRE, MD, 141466877 ext. +33, flavie.bompaire@intradef.gouv.fr
About this study
Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.
The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.
Read more
Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.
Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.
For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.
- Conditions
- Dysexecutive Syndrome
- Being tested
- Chocolate cake, Lego model, Measurement of sensorimotor abilities, Measurement of facial expression of emotions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chocolate cakeBehavioural
The participants will have to make a chocolate cake following an imposed recipe at 4 visits (initially (M0), after 12 months (M12), after 24 months (M24) and after 36 months (M36)).
Lego modelBehavioural
The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).
Measurement of sensorimotor abilitiesDevice
The measurement of sensorimotor abilities is based on a multi-sensor device called Smart Flat specifically designed for this study at 4 visits (M0, M12, M24 and M36).
Measurement of facial expression of emotionsOther
Participants will have to evoke an emotionally charged autobiographical story by modulating facial expressions through a mirror at 4 visits (M0, M12, M24 and M36).
| Study group | Role | What they receive |
|---|---|---|
| Dysexecutive patients | Patients with dysexecutive syndrome Receives: Behavioral: Chocolate cake; Behavioral: Lego model; Device: Measurement of sensorimotor abilities; Other: Measurement of facial expression of emotions | |
| Healthy subjects | Healthy subjects to be used as control group Receives: Behavioral: Chocolate cake; Behavioral: Lego model; Device: Measurement of sensorimotor abilities; Other: Measurement of facial expression of emotions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest number of errors on the executive tasks over the 4 visits
An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary The number of errors will be calculated for each task at each visit. The lowest number will be retained to compare the 2 groups.
Measured: Until the end of the study (3 years)
Secondary outcomes (2)
Lowest number of errors on the Lego model task over the 4 visits
An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary
The number of errors will be calculated for the Lego model task at each visit. The lowest number will be retained to compare the 2 groups.
Measured: Until the end of the study (3 years)
Lowest number of errors on the chocolate cake task over the 4 visits
An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary
The number of errors will be calculated for the chocolate cake task at each visit.
The lowest number will be retained to compare the 2 groups.
Measured: Until the end of the study (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start13 Oct 2021
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysexecutive SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017051
- Sponsor's protocol ID
- 2018PPRC34
- Other IDs
- 2021-A00087-34
- Acronym
- SDS2
- Status last verified
- Dec 2022
- First submitted
- 19 Aug 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT05017051
- Acronym / sponsor ID
- SDS2 / 2018PPRC34
- Conditions
- Dysexecutive Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 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.
Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.
The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.
Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.
Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.
For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysexecutive patients | – | Behavioral: Chocolate cake, Behavioral: Lego model, Device: Measurement of sensorimotor abilities, Other: Measurement of facial expression of emotionsPatients with dysexecutive syndrome |
| Healthy subjects | – | Behavioral: Chocolate cake, Behavioral: Lego model, Device: Measurement of sensorimotor abilities, Other: Measurement of facial expression of emotionsHealthy subjects to be used as control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of 2 groups: * a group of patients with dysexecutive syndrome * a group of healthy subjects
Key inclusion criteria (2 listed)
- Patients with a dysexecutive syndrome OR healthy subjects
- Over 18 years-old
Key exclusion criteria (6 listed)
- Patients
- Healthy 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 |
|---|---|---|
| Chocolate cakeThe participants will have to make a chocolate cake following an imposed recipe at 4 visits (initially (M0), after 12 months (M12), after 24 months (M24) and after 36 months (M36)). | Behavioural | Dysexecutive patients, Healthy subjects |
| Lego modelThe participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36). | Behavioural | Dysexecutive patients, Healthy subjects |
| Measurement of sensorimotor abilitiesThe measurement of sensorimotor abilities is based on a multi-sensor device called Smart Flat specifically designed for this study at 4 visits (M0, M12, M24 and M36). | Device | Dysexecutive patients, Healthy subjects |
| Measurement of facial expression of emotionsParticipants will have to evoke an emotionally charged autobiographical story by modulating facial expressions through a mirror at 4 visits (M0, M12, M24 and M36). | Other | Dysexecutive patients, Healthy subjects |
Primary outcome
Lowest number of errors on the executive tasks over the 4 visits
Time frame: Until the end of the study (3 years)
An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary The number of errors will be calculated for each task at each visit. The lowest number will be retained to compare the 2 groups.
2 secondary outcomes
Lowest number of errors on the Lego model task over the 4 visits
Time frame: Until the end of the study (3 years)
Lowest number of errors on the chocolate cake task over the 4 visits
Time frame: Until the end of the study (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Dysexecutive Syndrome
Active, not recruiting
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19
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.
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 Dysexecutive Syndrome, run by Direction Centrale du Service de Santé des Armées 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavie BOMPAIRE, MD (141466877 ext. +33, flavie.bompaire@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowest number of errors on the executive tasks over the 4 visits (time frame: Until the end of the study (3 years)). 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 21 Dec 2022; AzTrials last refreshed its copy on 26 Oct 2026.