Emotion Study/Substudy: Flexible Brain Study

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872414
• Other study ID #: IRB201300814-PD -N
• Secondary ID: 1R21AG057200UL1T
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Emotions
• Parkinson Disease

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	Florida Department of Health, National Center for Advancing Translational Sciences (NCATS), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BOLD signal response	Change in blood-oxygen-level dependent (BOLD) signal response of the anterior cingulate cortex.	Baseline; Day 8