Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa
28 février 2022 mis à jour par: University of Minnesota
The purpose of the study is to evaluate the use of a new brain stimulation tool called transcranial direct current stimulation (tDCS).
tDCS is a new technique used to stimulate the brain.
The investigators believe that it may help to change brain function in individuals with anorexia nervosa.
The brain stimulation occurs outside the head.
The tDCS procedure involves applying a small amount of electrical current across the scalp, for a short period of time.
This small electrical current is able to change the electrical activity inside areas of the brain.
In the current study, the investigators will ask participants to complete computer-based brain training sessions.
While participants do the brain training exercises, they will receive either real tDCS for "sham" tDCS.
"Sham" tDCS means that participants might feel sensations like tingling or vibrations from the tDCS machine, but will not actually receive the electrical current.
Investigators will also ask participants to complete several tests to assess changes in brain function.
The information gained from this study will help investigators to understand how tDCS could be used to improve brain function and learning in individuals with anorexia nervosa.
Aperçu de l'étude
Statut
Retiré
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age 18+ years
- Documented enrollment in residential-level treatment at The Emily Program and meeting criteria for AN (BMI <18.5).
- Participant must be capable of giving informed consent, based on University of California San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC)39 risk assessment, which has been uploaded to ETHOS.
- Sufficient spoken English so as to be able to comprehend testing procedures.
Exclusion Criteria:
- Substance abuse in the participant
- Neurological condition or other developmental disorder
- Serious psychiatric disorder known to affect brain functioning and cognitive performance
- Medical instability, which will be evident based on required admittance status in the residential treatment facility from which participants will be recruited. (The Emily Program residential treatment patients are followed closely by a medical provider, who routinely assesses medical stability throughout the duration of each patient's stay in the treatment facility; therefore, if a participant is not currently a patient in this setting and/or has been recently discharged from residential treatment setting due to medical need to receive higher level of care/inpatient-level care, they will be excluded from enrollment in this study).
- MRI contraindication [based on Center for Magnetic Resonance Research (CMRR) prescreening protocol]
- tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Active tDCS
Participants will receive 10 sessions of active tDCS + cognitive training.
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Transcranial direct current stimulation, involving low-levels of electrical stimulation applied to the right and left DLPFC will be used in conjunction with cognitive training for 46 minutes.
|
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Comparateur factice: Sham tDCS
Participants will receive 10 sessions of sham tDCS + cognitive training.
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Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and rate of treatment dropout in treatment-seeking adults with AN receiving treatment in a residential treatment program for eating disorders.
Délai: Through study completion, an average of 1 year.
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Treatment-related adverse events will be assessed by CTCAE v4.0 criteria.
Participant dropout will be examined in effort to evaluate whether individuals with AN will tolerate the procedures and remain in the study.
This will be evinced by less than 20% dropout over the course of active tDCS and cognitive training.
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Through study completion, an average of 1 year.
|
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Change from Baseline to End of Treatment Set-Shifting Task Performance Following 10-session tDCS + Cognitive Training Intervention Protocol.
Délai: Through study completion, an average of 1 year.
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Changes in cognitive flexibility will be assessed by examining differences between baseline and end of treatment performance on reversal learning task.
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Through study completion, an average of 1 year.
|
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Change from Baseline to End of Treatment Resting State and Task-based Functional Magnetic Resonance Imaging (fMRI) Activation during Reversal Learning Task Following 10-session tDCS + Cognitive Training Intervention Protocol.
Délai: Through study completion, an average of 1 year.
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Changes in brain circuitry assessed during resting state and task-based fMRI will be assessed to examine whether active tDCS is associated with greater change in associated circuitry, as compared with sham tDCS.
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Through study completion, an average of 1 year.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Eating Disorder Examination (EDE) Scores from Baseline to End of Treatment
Délai: Through study completion, an average of 1 year.
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Change in eating disorder psychopathology, measured by the EDE, will be evaluated over the course of a 10-session tDCS + cognitive training intervention to determine whether tDCS is associated with significant change in eating pathology among individuals with Anorexia Nervosa.
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Through study completion, an average of 1 year.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kelvin O Lim, MD, PhD, University of Minnesota
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 août 2019
Achèvement primaire (Réel)
31 décembre 2021
Achèvement de l'étude (Réel)
31 décembre 2021
Dates d'inscription aux études
Première soumission
24 juillet 2018
Première soumission répondant aux critères de contrôle qualité
22 août 2018
Première publication (Réel)
27 août 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 février 2022
Dernière vérification
1 février 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PSYCH-2018-26509
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
There is no plan to share Individual Participant Data (IPD) with other researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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