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Completed

NCT Number: NCT03872414

Emotion Study/Substudy: Flexible Brain Study

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611-2250, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Change in BOLD signal response

    Time frame: Baseline; Day 8

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2019
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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