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- Klinische proef NCT05457725
Modulerende neurocognitieve processen van leren vertrouwen en wantrouwen bij veroudering (DecidingBrain)
Karakteriseren en moduleren van neurocognitieve processen van leren vertrouwen en wantrouwen bij ouder worden II
Much of human interaction is based on trust. Aging has been associated with deficits in trust-related decision making, likely further exacerbated in age-associated neurodegenerative disease (Alzheimer's disease/AD), possibly underlying the dramatically growing public health problem of elder fraud. Optimal trust-related decision making and avoiding exploitation require the ability to learn about the trustworthiness of social partners across multiple interactions, but the role that learning plays in determining age deficits in trust decisions is currently unknown.
Aim: Probe the malleability of the underlying neurocircuitry of trust-learning deficits in aging. This study will utilize real-time fMRI neurofeedback to train older adults in brain activity up-regulation toward enhanced trust-related learning in aging and confirm critical mechanisms of experience-dependent social decisions in aging.
Grant R01AG072658 Aim 3: Test the malleability of trust-learning neurocircuitry toward optimized trust-related decision making in aging.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
This study will apply rtfMRI neurofeedback training as an intervention method, to demonstrate that older adults can be trained in volitional brain activity up-regulation, reducing their trust-learning deficits. The study will comprises several MRI sessions including pre-training, training, and post-training scans.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Alyssa Hayes
- Telefoonnummer: (352) 273-2134
- E-mail: alyssa.hayes@ufl.edu
Studie Contact Back-up
- Naam: Sarah G. Verdecia-Zabala
- E-mail: sverdeciazabala@ufl.edu
Studie Locaties
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Florida
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Gainesville, Florida, Verenigde Staten, 32611
- Werving
- University of Florida
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Hoofdonderzoeker:
- Natalie Ebner, PhD
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Contact:
- Dana Arnold
- Telefoonnummer: 352-273-2141
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Able to provide verbal and written informed consent
- Fluent English speaker
- At least 8th grade education
- On stable medication regimen
Exclusion Criteria:
- Pregnancy
- Magnetic resonance imaging contraindications (e.g., certain metallic objects in body, claustrophobia)
- Current major depression defined as scores >14 on the Beck Depression Inventory-II
- Impaired scores on the Telephone Interview for Cognitive Status (TICS; cut-off of >30)
- Current use of medications with significant anticholinergic properties due to potential influence on memory ("memory enhancing"; e.g., Aricept or Namenda)
- Current use of anticonvulsant, neuroleptic, sedatives, or other medications known to affect cognition
- Uncorrected visual and hearing impairments
- Neurologic conditions affecting the brain (e.g., severe stroke, epilepsy, traumatic brain injury with >30-minute loss of consciousness)
- Impaired scores on a cognitive screening measure, the Montreal Cognitive Assessment (MoCA); for older adults the cutoff will be age and education corrected
- Unstable medical illness (e.g., metastatic cancer)
- Significant cardiovascular conditions (e.g., major heart attack)
- Will not exclude participants who are taking anti-depressant medications. Use of antidepressants (particularly SSRI's) and anxiolytic medications will be recorded and included in post-hoc analyses
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Contingent rtfMRI neurofeedback training
Contingent rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about real-time brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static. |
Contingent rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about real-time brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static. |
|
Sham-vergelijker: Non-contingent/sham rtfMRI neurofeedback training
Non-contingent/sham rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about non-contingent/sham brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static. |
Non-contingent/sham rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about non-contingent/sham brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Neurofeedback Training Success
Tijdsspanne: at baseline and after training completion about 1 week later
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Increase in BOLD signal in ROI during up-regulation trials administration of computerized learning tasks, with contrasting groups and conditions |
at baseline and after training completion about 1 week later
|
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Behavioral Benefits
Tijdsspanne: at baseline and after training completion about 1 week later
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Increase in trust-related learning reflected in greater accuracy (e.g., in percent) on trust learning task |
at baseline and after training completion about 1 week later
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Natalie C. Ebner, PhD., University of Florida
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB202400337
- R01AG072658 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
De-identified data may be shared with other researchers for secondary data analysis.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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product vervaardigd in en geëxporteerd uit de V.S.
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