- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02194907
Emotion Study -- A Neurofeedback Approach
Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32611-2250
- University of Florida
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 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
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Increased activation of anterior insula from pre-training to post-training
Periodo de tiempo: 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.
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Pre-training session (baseline visit); post-training session (approximately one week later)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Natalie Ebner, PhD, University of Florida, Department of Psychology
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB201300814 closed
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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