- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Saint-etienne, Frankrig, 42000
- Chu de Saint-Etienne
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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. |
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Eksperimentel: 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. |
|
Eksperimentel: 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). |
|
Eksperimentel: 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). |
|
Aktiv komparator: 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. |
|
Aktiv komparator: 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. |
|
Aktiv komparator: 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). |
|
Aktiv komparator: 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Response time (ms) in the different conditions of the three tasks (composite measure)
Tidsramme: Day 1
|
Tasks are:
|
Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BMI in kg/m²
Tidsramme: Day 1
|
The Body Mass Index (BMI) is defined as the body mass divided by the square of the body height.
|
Day 1
|
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Rate of wrong answers
Tidsramme: Day 1
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It is the rate of wrong answers in the different conditions of the three tasks.
|
Day 1
|
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Score EDI-2
Tidsramme: Day 1
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The Eating Disorder Inventory (EDI) is a self-report questionnaire used to assess the presence of eating disorders.
|
Day 1
|
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Silhouettes test score
Tidsramme: Day 1
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The patient selects among several silhouettes a silhouette to represent her real body image and her ideal body image.
|
Day 1
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Catherine MASSOUBRE, MD PhD, Chu de Saint-Etienne
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1001179
- 2010-A01523-36 (Anden identifikator: ANSM)
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Kliniske forsøg med Anoreksi
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Rosemary Claire RodenChildren's Miracle NetworkAfsluttetBulimia nervosa | Impulsiv adfærd | Udrensning (spiseforstyrrelser) | Spiseforstyrrelser | Spiseforstyrrelser i ungdomsårene | Anorexia Nervosa/Bulimi | Anoreksi i ungdomsårene | Anorexia Nervosa, atypisk | Anorexia Nervosa, overspisning/udskylningstypeForenede Stater
-
Baylor College of MedicineTilmelding efter invitationAnoreksi | Atypisk anorexia nervosaForenede Stater
-
Duke UniversityAfsluttetTeenagers Anorexia Nervosa | Undertærskel Anorexia NervosaForenede Stater
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RekrutteringAnoreksi | Anorexia Nervosa i remission | Anorexia Nervosa-begrænsende typeSpanien
-
University of California, San DiegoAktiv, ikke rekrutterendeAnoreksi | Bulimia nervosa | Atypisk anorexia nervosa | Atypisk bulimia nervosaForenede Stater
-
University of California, San DiegoRekrutteringAnoreksi | Bulimia nervosa | Anorexia Nervosa i remissionForenede Stater
-
The Miriam HospitalUkendtSpiseforstyrrelser i ungdomsårene | Anorexia Nervosa/Bulimi | Anorexia Nervosa-begrænsende typeForenede Stater
-
Maimónides Biomedical Research Institute of CórdobaHospital Universitario Reina Sofia de CordobaIkke rekrutterer endnuAnorexia Nervosa-begrænsende type | Anorexia Nervosa (Reviderede DSM-IV-kriterier)Spanien
-
Denver Health and Hospital AuthorityAfsluttetUndgå restriktiv fødeindtagelsesforstyrrelse | Anorexia Nervosa, overspisning/udskylningstype | ARFID | Anorexia Nervosa-begrænsende typeForenede Stater
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Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health... og andre samarbejdspartnereAfsluttetAnoreksi | Anoreksi | Spiseforstyrrelse | Spiseforstyrrelser i ungdomsårene | Anoreksi i ungdomsårene | Anorexia Nervosa, atypisk | Anorexia Nervosa-begrænsende type | Anoreksi hos børnForenede Stater
Kliniske forsøg med TEA + Grober Test + Task 1 + Grober Test
-
Karamanoğlu Mehmetbey UniversityKaraman Training and Research HospitalAfsluttetSkoliose idiopatiskTyrkiet (Türkiye)
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Yonsei UniversityAfsluttetPostprandial hyperglykæmi
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Afyonkarahisar Health Sciences UniversityRekruttering
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Assistance Publique - Hôpitaux de ParisRekrutteringOndine syndrom | Medfødt centralt hypoventilationssyndrom (CCHS)Frankrig
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University College of Northern DenmarkRekruttering
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Coloplast A/SAfsluttetIleostomi - StomiDanmark
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Coloplast A/SAfsluttetIleostomi - StomiHolland
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University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID); University...Afsluttet
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-
University of FloridaAfsluttetParkinsons sygdom (PD)Forenede Stater