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Emotion Study/Substudy: Flexible Brain Study

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ClinicalTrials.gov Identifier: NCT03872414
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

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 insula cortex activation Behavioral: Primary auditory cortex activation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Younger Group
Participants will receive rt-fMRI training to increase anterior insula cortex activation.
Behavioral: Anterior insula 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 insula cortex.

The anterior insula 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 insula cortex activation.
Behavioral: Anterior insula 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 insula cortex.

The anterior insula 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 insula cortex activation.
Behavioral: Anterior insula 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 insula cortex.

The anterior insula 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).




Primary Outcome Measures :
  1. Change in BOLD signal response [ Time Frame: Baseline; Day 8 ]
    Change in blood-oxygen-level dependent (BOLD) signal response of the anterior insula cortex.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Young adults

  • aged 18-35 years of age
  • right-handed
  • 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
  • right-handed
  • 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
  • right-handed
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872414


Contacts
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Contact: Ebner Lab 352-273-2141 Psy-ebnerlab@psych.ufl.edu

Locations
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United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611-2250
Contact: Ebner Lab    352-273-2141    Psy-ebnerlab@psych.ufl.edu   
Principal Investigator: Natalie Ebner, PhD         
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Natalie Ebner, PhD University of Florida, Department of Psychology

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03872414     History of Changes
Other Study ID Numbers: IRB201300814-PD -N
1R21AG057200 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Emotional Aging
Neurofeedback

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases