Emotion Study/Substudy: Flexible Brain Study

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT03872414

Collaborator

National Institute on Aging (NIA) (NIH), Ed and Ethel Moore Alzheimer's Disease Research Program (Other)

226

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Emotions Parkinson Disease	Behavioral: Anterior cingulate cortex activation Behavioral: Primary auditory cortex activation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Emotion Study (Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach)/Substudy: Flexible Brain Study

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Younger Group Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.	Behavioral: Anterior cingulate cortex activation Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior cingulate cortex. The anterior cingulate cortex is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing.
Experimental: Healthy Older Group Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.	Behavioral: Anterior cingulate cortex activation Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior cingulate cortex. The anterior cingulate cortex is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing.
Experimental: Parkinson Disease Group Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.	Behavioral: Anterior cingulate cortex activation Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior cingulate cortex. The anterior cingulate cortex is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing.
Active Comparator: Control Group Participants will receive rt-fMRI training to increase primary auditory cortex activation.	Behavioral: Primary auditory cortex activation Functional Magnetic Resonance Imaging Participants in each group will be trained using functional magnetic resonance imaging to regulation brain activity in primary auditory cortex. The primary auditory cortex is a brain region that is NOT specifically involved in emotion processing. Activation of this region is NOT expected to improve emotion processing; and thus activation of this brain region serves as "control/placebo" condition in the current design (placebo comparator).

Outcome Measures

Primary Outcome Measures

Change in BOLD signal response [Baseline; Day 8]
Change in blood-oxygen-level dependent (BOLD) signal response of the anterior cingulate cortex.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32611-2250

Sponsors and Collaborators

University of Florida
National Institute on Aging (NIA)
Ed and Ethel Moore Alzheimer's Disease Research Program

Investigators

Principal Investigator: Natalie Ebner, PhD, University of Florida, Department of Psychology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT03872414

Other Study ID Numbers:

IRB201300814-PD -N
1R21AG057200
UL1TR001427
20A15

First Posted:

Mar 13, 2019

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Florida

Emotional Aging

Neurofeedback

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jun 13, 2022