Clinical trial NCT03872414: Emotion Study/Substudy: Flexible Brain Study
Official title: Emotion Study (Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach)/Substudy: Flexible Brain Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Emotions
Parkinson Disease
Keywords: Emotional Aging
Neurofeedback
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Florida Department of Health
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-03-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The proposed research applies the highly innovative technology of real-time functional Magnetic Resonance Imaging (rtfMRI) to examine plasticity of brain-regulatory mechanisms related to cognitive and affective processing and to determine benefits for cognition and affect in young and older adults and in Parkinson Disease (PD) patients.

Detailed description: There is increasing evidence that age-related alterations in brain function associated with affective processing and attention contribute to these motivational and emotional changes with age.

Based on these theoretical considerations as well as the previous study's data, the proposed research will apply well-tested emotion processing and attention paradigms to address the pivotal question of whether brain activity can be modulated in healthy aging and PD (in the substudy) via contingent rt-fMRI neurofeedback and whether this neuroregulatory modulation increases emotion processing and cognitive performance.

Eligibility criteria: Inclusion Criteria: Young adults

* aged 18-35 years of age
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy as determined by the Health Demographics Screener
* eligible for MRI as determined by the MRI Eligibility Interview (including not being pregnant)
* scores within normal limits on a cognitive screener (MoCA)
* no indication of serious psychiatric disturbance including major depression (based on Mental Health Screener)
* willing and able to give informed consent

Inclusion Criteria: Older adults

* age 55-100 years of age
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy as determined by the Health Demographics Screener
* eligible for MRI as determined by the MRI Eligibility Interview
* no indication of dementia based on score of 30 or above on the Telephone Interview for Cognitive Status and nonimpaired score on the Montreal Cognitive Assessment (MoCA -- score of 22 and above)
* no indication of serious psychiatric disturbance including current major depression (based on Mental Health Screener)
* willing and able to give informed consent

Inclusion Criteria: Parkinson patients

* must meet criteria for diagnosis of idiopathic Parkinson disease according the UK Brain Bank by a movement trained neurologist.
* age 55-100 years of age
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy other than Parkinson disease
* eligible for MRI as determined by the MRI Eligibility Interview
* no indication of dementia based on cognitive screening measures (TICS -- score of 30 or above, and MoCa -- score of 22 and above)
* no indication of serious psychiatric disturbance including current major depression
* willing and able to give informed consent

Inclusion Criteria: Individuals with SCD and a family history of dementia or Alzheimer's disease

* age 55-100 years of age
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy as determined by the Health Demographics Screener
* eligible for MRI as determined by the MRI Eligibility Interview
* no indication of dementia based on score of 30 or above on the Telephone Interview for Cognitive Status and nonimpaired score on the Montreal Cognitive Assessment (MoCA -- score of 22 and above)
* no indication of serious psychiatric disturbance including current major depression (based on Mental Health Screener)
* willing and able to give informed consent
* community-dwelling with subjective report of cognitive complaints with scores \>16 on the Cognitive Change Index (CCI-20)
* no evidence of dementia or mild cognitive impairment based on cognitive screening using the MoCA; scores must fall within normal limits for age, education, and sex
* no psychometric evidence of neuropsychological impairment on a modified Neuropsychological Battery from the NACC Unified Data Set, version 3
* score of 0 on the Global Clinic Dementia Rating (CDR) scale
* normal functional behavior in terms of daily activities, based on the Functional Activities Scale (FAQ)
* availability of an informant (over the phone) who can provide information about the participant's complaints using the informant version of the CCI-20, and corroborate normal activities of daily living on the FAQ and the CDR scale.

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
* use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
* use of prescribed 'memory enhancing' medications such as Aricept or Namenda.

Primary outcomes:
measure: Change in BOLD signal response
timeFrame: Baseline; Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida, Department of Psychology
name: Natalie Ebner, PhD
role: PRINCIPAL_INVESTIGATOR
References: