Emotion Study -- A Neurofeedback Approach
21 janvier 2020 mis à jour par: University of Florida
Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach
This study will determine whether brain activity can be modified and improves performance on a task by showing participants live 'video feed' of their brains on advanced imaging technology.
The study is particularly interested in brain regions that have been shown to be relevant for emotions, specifically the anterior insula and the medial prefrontal cortex.
Advanced technology will map the brain using magnetic pulses with a real-time functional Magnetic Resonance Imaging (rt-fMRI) machine.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Overview: All participants of both age groups will be randomly divided (like tossing a coin) into two groups:
- One group will have training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text
- The other group will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text
Further, each of these two groups will be divided into two sub-groups that are different with respect to the training procedure that is used:
* Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training, that has not been associated with any known side effects or safety risks
Number of Study Visits:
This study has the following parts: A pre-training visit, six training visits, and a post-training visit.
With a few exceptions as explained below, the procedures during pre-training, training, and post-training visits are identical.
- At the beginning of the first visit, the investigator will tell the participant about the study and what is involved and will ask them to sign a consent form. The participant may ask as many questions as they would like before deciding about study participation.
- For each of the visits, the investigator will review questions with the participant about their health to ensure their eligibility to undergo fMRI on the day of testing.
- Also for each visit, the investigator will ask the participant to respond to a short questionnaire related to their current mood.
- In the pre-training and the post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts.
- For each of the participant's visits, they will spend 50-60 minutes either in the MRI scanner, while viewing pictures and text on a screen. During this time, pictures of the participant's brain at work and at rest will be acquired. In the training visits only, the participant will learn to increase blood flow in certain brain regions with the help of information presented to them on the screen.
- For each of the participant's visits, they will be asked to respond to a short questionnaire related to their current mood.
- In the pre-training/post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts as well as their personality. The participant will also perform brief tests related to the thinking process.
- At the end of each visit, the participant will complete a questionnaire about how they approached the study tasks and whether they experienced any discomfort in the MRI scanner or while wearing the fNIRS system.
- Upon study completion, the investigator will tell the participant about the general goals of the study and answer any questions that they may have.
The procedure can be stopped at any time.
The study will conclude with debriefing and reimbursement.
Type d'étude
Interventionnel
Inscription (Réel)
19
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
-
-
Florida
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Gainesville, Florida, États-Unis, 32611-2250
- University of Florida
-
-
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 à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Between the ages of 18-30 years or 63-90 years
- Right-handed
- Native English speaker
Exclusion Criteria:
- Pregnant or possibly pregnant
- Claustrophobia
- Large pieces of metal in the body, particularly in the face and neck.
- Piercings or metal implants that cannot be removed from the body
- Surgery on the brain or any prior serious brain damage or disease
- Dementia or severe cognitive disorders
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: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Anterior insula cortex activation
Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text.
|
training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
|
|
Comparateur actif: Primary auditory cortex activation
Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text.
|
training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Increased activation of anterior insula from pre-training to post-training
Délai: Pre-training session (baseline visit); post-training session (approximately one week later)
|
Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
|
Pre-training session (baseline visit); post-training session (approximately one week later)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
Délai: Pre-training (baseline visit); post-training visit (approximately one week later)
|
Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.
|
Pre-training (baseline visit); post-training visit (approximately one week later)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Natalie Ebner, PhD, University of Florida, Department of Psychology
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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
1 octobre 2014
Achèvement primaire (Réel)
8 janvier 2020
Achèvement de l'étude (Réel)
8 janvier 2020
Dates d'inscription aux études
Première soumission
10 juillet 2014
Première soumission répondant aux critères de contrôle qualité
17 juillet 2014
Première publication (Estimation)
18 juillet 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB201300814 closed
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
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