AgingNCT03872414
Emotion Study/Substudy: Flexible Brain Study
A study testing Anterior cingulate cortex activation and Primary auditory cortex activation in people with Aging and Emotions, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Emotions, Parkinson Disease
- What is being tested?
- Anterior cingulate cortex activation and Primary auditory cortex activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 40Show fewer
- 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)
- willing and able to give informed consent
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32611-2250
About this study
Official title: Emotion Study (Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach)/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.
Read the 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.
- Conditions
- Aging, Emotions, Parkinson Disease
- Being tested
- Anterior cingulate cortex activation, Primary auditory cortex activation
- Keywords
- Emotional Aging, Neurofeedback
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cingulate cortex activationBehavioural
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 activationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Younger Group | Experimental | Participants will receive rt-fMRI training to increase anterior cingulate cortex activation. Receives: Behavioral: Anterior cingulate cortex activation |
| Healthy Older Group | Experimental | Participants will receive rt-fMRI training to increase anterior cingulate cortex activation. Receives: Behavioral: Anterior cingulate cortex activation |
| Parkinson Disease Group | Experimental | Participants will receive rt-fMRI training to increase anterior cingulate cortex activation. Receives: Behavioral: Anterior cingulate cortex activation |
| Control Group | Active comparator | Participants will receive rt-fMRI training to increase primary auditory cortex activation. Receives: Behavioral: Primary auditory cortex activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOLD signal response
Change in blood-oxygen-level dependent (BOLD) signal response of the anterior cingulate cortex.
Measured: Baseline; Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2019
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Florida Department of Health, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Natalie Ebner, PhD, Principal investigator, University of Florida, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872414
- Sponsor's protocol ID
- IRB201300814-PD -N
- Other IDs
- 1R21AG057200, UL1TR001427, 20A15
- Status last verified
- May 2023
- First submitted
- 11 Mar 2019
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Study (Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach)/Substudy: Flexible Brain Study
- ClinicalTrials.gov ID
- NCT03872414
- Acronym / sponsor ID
- IRB201300814-PD -N
- Conditions
- Aging, Emotions, Parkinson Disease
- Keywords
- Emotional Aging, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Florida Department of Health, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Younger Group | Experimental | Behavioral: Anterior cingulate cortex activationParticipants will receive rt-fMRI training to increase anterior cingulate cortex activation. |
| Healthy Older Group | Experimental | Behavioral: Anterior cingulate cortex activationParticipants will receive rt-fMRI training to increase anterior cingulate cortex activation. |
| Parkinson Disease Group | Experimental | Behavioral: Anterior cingulate cortex activationParticipants will receive rt-fMRI training to increase anterior cingulate cortex activation. |
| Control Group | Active comparator | Behavioral: Primary auditory cortex activationParticipants will receive rt-fMRI training to increase primary auditory cortex activation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior cingulate cortex activationFunctional 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. | Behavioural | Healthy Older Group, Healthy Younger Group, Parkinson Disease Group |
| Primary auditory cortex activationFunctional 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). | Behavioural | Control Group |
Primary outcome
Change in BOLD signal response
Time frame: Baseline; Day 8
Change in blood-oxygen-level dependent (BOLD) signal response of the anterior cingulate cortex.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Ebner, PhD principal investigator
University of Florida, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cingulate cortex activation and Primary auditory cortex activation in people with Aging and Emotions, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BOLD signal response (time frame: Baseline; Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.