- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02538796
The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa.
The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Saint-etienne, Francie, 42000
- Chu de Saint-Etienne
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria for patients:
- Restrictive anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM IV-TR)
- BMI> 16 to avoid the effects of undernutrition
- Start disorders <10 years
- Right handed
- Having given free and informed consent prior to study participation
- Subject affiliated to the French National Health Insurance
Inclusion Criteria for control group:
- BMI between 18,5 and 25
- Right handed
- Of school level paired in that of the patients (+/-1 the year)
- Having given free and informed consent prior to study participation
- Subject affiliated to the French National Health Insurance
Exclusion Criteria for patients and control group:
- Patients with at the beginning or during the study form of purgative anorexia nervosa
- Control with disorders of current or past eating behavior.
- Control making a restrictive diet during the study period
- Participants with depressive table
- Participants with a somatic problem restricted movement or a problem of uncorrected visual acuity annoying reading of the screen.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Patients group 1
TEA + Grober Test + Task 1 + Grober Test
|
The Test of Everyday Attention (TEA) measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 1 consists of a stimulus that moves on the screen. The response of the patient is done on the keyboard. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
Experimentální: Patients group 2
TEA + Grober Test + Task 2 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 2 consists of a stimulus that is fixed on the screen. The response of the patient is done by pushing or pulling a lever. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
Experimentální: Patients group 3
TEA + Grober Test + Implicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are implicit condition to detect an A in the word ("yes-no" answer). |
Experimentální: Patients group 4
TEA + Grober Test + Explicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are explicit condition to judge the emotional value of words ("positive-negative" answer). |
Aktivní komparátor: Healthy volonteers group 1
TEA + Grober Test + Task 1 + Grober Test
|
The Test of Everyday Attention (TEA) measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 1 consists of a stimulus that moves on the screen. The response of the patient is done on the keyboard. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
Aktivní komparátor: Healthy volonteers group 2
TEA + Grober Test + Task 2 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 2 consists of a stimulus that is fixed on the screen. The response of the patient is done by pushing or pulling a lever. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
Aktivní komparátor: Healthy volonteers group 3
TEA + Grober Test + Implicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are implicit condition to detect an A in the word ("yes-no" answer). |
Aktivní komparátor: Healthy volonteers group 4
TEA + Grober Test + Explicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are explicit condition to judge the emotional value of words ("positive-negative" answer). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Response time (ms) in the different conditions of the three tasks (composite measure)
Časové okno: Day 1
|
Tasks are:
|
Day 1
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
BMI in kg/m²
Časové okno: Day 1
|
The Body Mass Index (BMI) is defined as the body mass divided by the square of the body height.
|
Day 1
|
Rate of wrong answers
Časové okno: Day 1
|
It is the rate of wrong answers in the different conditions of the three tasks.
|
Day 1
|
Score EDI-2
Časové okno: Day 1
|
The Eating Disorder Inventory (EDI) is a self-report questionnaire used to assess the presence of eating disorders.
|
Day 1
|
Silhouettes test score
Časové okno: Day 1
|
The patient selects among several silhouettes a silhouette to represent her real body image and her ideal body image.
|
Day 1
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Catherine MASSOUBRE, MD PhD, Chu de Saint-Etienne
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1001179
- 2010-A01523-36 (Jiný identifikátor: ANSM)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na TEA + Grober Test + Task 1 + Grober Test
-
University Hospital, BordeauxDokončeno
-
Afyonkarahisar Health Sciences UniversityNábor
-
Yonsei UniversityDokončenoPostprandiální hyperglykémie
-
University of FloridaDokončenoParkinsonova nemoc (PD)Spojené státy
-
Coloplast A/SDokončenoIleostomie – StomieDánsko
-
Coloplast A/SDokončenoIleostomie – StomieHolandsko
-
Clinical Nutrition Research Centre, SingaporeDokončeno
-
Imperial College Healthcare NHS TrustDokončenoZtráta sluchu, způsobená hlukemSpojené království
-
Hacettepe UniversityNeznámýKapacita cvičení | Cystická fibróza u dětíKrocan
-
Janssen Research & Development, LLCDokončeno