Emotion Study/Substudy: Flexible Brain Study

NCT03872414 | Completed

• 4 other identifiers: IRB201300814-PD -N1R21AG057200UL1TR00142720A15
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Emotions; Parkinson Disease

Keywords

Emotional Aging; Neurofeedback

Outcome Measures

Primary Outcomes (1)

• Change in BOLD signal response

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

  Baseline; Day 8

Study Arms (4)

Healthy Younger Group

EXPERIMENTAL

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

Behavioral: Anterior cingulate cortex activation

Healthy Older Group

EXPERIMENTAL

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

Behavioral: Anterior cingulate cortex activation

Parkinson Disease Group

EXPERIMENTAL

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

Behavioral: Anterior cingulate cortex activation

Control Group

ACTIVE COMPARATOR

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

Behavioral: Primary auditory cortex activation

Interventions

Anterior cingulate cortex activation BEHAVIORAL

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.

Healthy Older Group; Healthy Younger Group; Parkinson Disease Group

Primary auditory cortex activation BEHAVIORAL

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).

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• Florida Department of Health: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611-2250, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Natalie Ebner, PhD

  University of Florida, Department of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: April 1, 2019
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)