- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02194907
Emotion Study -- A Neurofeedback Approach
Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Florida
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Gainesville, Florida, Spojené státy, 32611-2250
- University of Florida
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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
|
Aktivní komparátor: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Increased activation of anterior insula from pre-training to post-training
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
Časové okno: Pre-training (baseline visit); post-training visit (approximately one week later)
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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.
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Pre-training (baseline visit); post-training visit (approximately one week later)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Natalie Ebner, PhD, University of Florida, Department of Psychology
Publikace a užitečné odkazy
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 (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB201300814 closed
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