Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients

Dysexecutive Syndrome Clinical Trial

— SDS2  

Official title:

Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017051
• Other study ID #: 2018PPRC34
• Secondary ID: 2021-A00087-34
• Status: Recruiting
• Start date: October 13, 2021
• Est. completion date: October 2028

Study information

• Verified date: December 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Flavie BOMPAIRE, MD
• Phone: 141466877
• Email: flavie.bompaire[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 442
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a dysexecutive syndrome OR healthy subjects

• Over 18 years-old

Exclusion Criteria:

• Patients

• Psychiatric pathology (except for Post-Traumatic Stress Disorder)

• Pregnant or breastfeeding woman

• Healthy subjects

• Neurologic or psychiatric pathology

• Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Cerebral Palsy
• Dysexecutive Syndrome

Intervention

Behavioral:
• Chocolate cake
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 model
The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).

Device:
• Measurement of sensorimotor abilities
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).

Other:
• Measurement of facial expression of emotions
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).

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Percy	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Until the end of the study (3 years)
Secondary	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.	Until the end of the study (3 years)
Secondary	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.	Until the end of the study (3 years)