Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients (SDS2)

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 Overview

• Status: Recruiting
• Conditions: Dysexecutive Syndrome
• Intervention / Treatment: Behavioral: Chocolate cake; Behavioral: Lego model; Device: Measurement of sensorimotor abilities; Other: Measurement of facial expression of emotions

• Study Type: Observational
• Enrollment (Anticipated): 442

Contacts and Locations

• Study Contact: Name: Flavie BOMPAIRE, MD; Phone Number: +33 141466877; Email: flavie.bompaire@intradef.gouv.fr

Study Locations

• France
  • Clamart, France, 92140
    • Recruiting
    • Hopital D'Instruction Des Armees Percy
    • Contact: Flavie BOMPAIRE, MD; Phone Number: +33 141466877; Email: flavie.bompaire@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of 2 groups:

• a group of patients with dysexecutive syndrome
• a group of healthy subjects

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dysexecutive patients; Patients with dysexecutive syndrome	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)).; Behavioral: 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).
Healthy subjects; Healthy subjects to be used as control group	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)).; Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Anticipated): October 1, 2028
• Study Completion (Anticipated): October 1, 2028

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2018PPRC34; 2021-A00087-34 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No