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Emotion Study/Substudy: Flexible Brain Study

Primary Purpose

Aging, Emotions, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior cingulate cortex activation
Primary auditory cortex activation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Emotional Aging, Neurofeedback

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Healthy Younger Group

Healthy Older Group

Parkinson Disease Group

Control Group

Arm Description

Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.

Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.

Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.

Participants will receive rt-fMRI training to increase primary auditory cortex activation.

Outcomes

Primary Outcome Measures

Change in BOLD signal response
Change in blood-oxygen-level dependent (BOLD) signal response of the anterior cingulate cortex.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2019
Last Updated
May 15, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), Florida Department of Health, National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03872414
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
May 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), Florida Department of Health, National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Emotions, Parkinson Disease
Keywords
Emotional Aging, Neurofeedback

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Younger Group
Arm Type
Experimental
Arm Description
Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.
Arm Title
Healthy Older Group
Arm Type
Experimental
Arm Description
Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.
Arm Title
Parkinson Disease Group
Arm Type
Experimental
Arm Description
Participants will receive rt-fMRI training to increase anterior cingulate cortex activation.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants will receive rt-fMRI training to increase primary auditory cortex activation.
Intervention Type
Behavioral
Intervention Name(s)
Anterior cingulate cortex activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Primary auditory cortex activation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in BOLD signal response
Description
Change in blood-oxygen-level dependent (BOLD) signal response of the anterior cingulate cortex.
Time Frame
Baseline; Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Ebner, PhD
Organizational Affiliation
University of Florida, Department of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611-2250
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotion Study/Substudy: Flexible Brain Study

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