AgingNCT02194907
Emotion Study -- A Neurofeedback Approach
A study testing Brain activity training - anterior insula and Brain activity training - medial prefrontal cortex in people with Aging and Emotion, run by University of Florida at 1 site in United States.
Trial summary
This study will determine whether brain activity can be modified and improves performance on a task by showing participants live 'video feed' of their brains on advanced imaging technology. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- Brain activity training - anterior insula and Brain activity training - medial prefrontal cortex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 8 Jan 2020
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-30 years or 63-90 years
- Right-handed
- Native English speaker
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
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
This study will determine whether brain activity can be modified and improves performance on a task by showing participants live 'video feed' of their brains on advanced imaging technology. The study is particularly interested in brain regions that have been shown to be relevant for emotions, specifically the anterior insula and the medial prefrontal cortex. Advanced technology will map the brain using magnetic pulses with a real-time functional Magnetic Resonance Imaging (rt-fMRI) machine.
Read the detailed description
Overview: All participants of both age groups will be randomly divided (like tossing a coin) into two groups:
- One group will have training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text
- The other group will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text
Further, each of these two groups will be divided into two sub-groups that are different with respect to the training procedure that is used:
- Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training, that has not been associated with any known side effects or safety risks
Number of Study Visits:
This study has the following parts: A pre-training visit, six training visits, and a post-training visit.
With a few exceptions as explained below, the procedures during pre-training, training, and post-training visits are identical.
- At the beginning of the first visit, the investigator will tell the participant about the study and what is involved and will ask them to sign a consent form. The participant may ask as many questions as they would like before deciding about study participation.
- For each of the visits, the investigator will review questions with the participant about their health to ensure their eligibility to undergo fMRI on the day of testing.
- Also for each visit, the investigator will ask the participant to respond to a short questionnaire related to their current mood.
- In the pre-training and the post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts.
- For each of the participant's visits, they will spend 50-60 minutes either in the MRI scanner, while viewing pictures and text on a screen. During this time, pictures of the participant's brain at work and at rest will be acquired. In the training visits only, the participant will learn to increase blood flow in certain brain regions with the help of information presented to them on the screen.
- For each of the participant's visits, they will be asked to respond to a short questionnaire related to their current mood.
- In the pre-training/post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts as well as their personality. The participant will also perform brief tests related to the thinking process.
- At the end of each visit, the participant will complete a questionnaire about how they approached the study tasks and whether they experienced any discomfort in the MRI scanner or while wearing the fNIRS system.
- Upon study completion, the investigator will tell the participant about the general goals of the study and answer any questions that they may have.
The procedure can be stopped at any time.
The study will conclude with debriefing and reimbursement.
- Being tested
- Brain activity training - anterior insula, Brain activity training - medial prefrontal cortex
- Keywords
- Emotional Aging, Neurofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain activity training - anterior insulaBehavioural
training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
Brain activity training - medial prefrontal cortexBehavioural
training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain
| Study group | Role | What they receive |
|---|---|---|
| Anterior insula cortex activation | Active comparator | Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text. Receives: Behavioral: Brain activity training - anterior insula |
| Primary auditory cortex activation | Active comparator | Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text. Receives: Behavioral: Brain activity training - medial prefrontal cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased activation of anterior insula from pre-training to post-training
Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
Measured: Pre-training session (baseline visit); post-training session (approximately one week later)
Secondary outcomes (1)
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.
Measured: Pre-training (baseline visit); post-training visit (approximately one week later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startOct 2014
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Ebner, PhD, Principal investigator, University of Florida, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194907
- Sponsor's protocol ID
- IRB201300814 closed
- Status last verified
- Jan 2020
- First submitted
- 10 Jul 2014
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. 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
- ClinicalTrials.gov ID
- NCT02194907
- Acronym / sponsor ID
- IRB201300814 closed
- Keywords
- Emotional Aging, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 18 Jul 2014 (estimated)
- 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.
This study will determine whether brain activity can be modified and improves performance on a task by showing participants live 'video feed' of their brains on advanced imaging technology. The study is particularly interested in brain regions that have been shown to be relevant for emotions, specifically the anterior insula and the medial prefrontal cortex. Advanced technology will map the brain using magnetic pulses with a real-time functional Magnetic Resonance Imaging (rt-fMRI) machine.
Detailed description
Overview: All participants of both age groups will be randomly divided (like tossing a coin) into two groups:
- One group will have training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text
- The other group will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text
Further, each of these two groups will be divided into two sub-groups that are different with respect to the training procedure that is used:
- Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training, that has not been associated with any known side effects or safety risks
Number of Study Visits:
This study has the following parts: A pre-training visit, six training visits, and a post-training visit.
With a few exceptions as explained below, the procedures during pre-training, training, and post-training visits are identical.
- At the beginning of the first visit, the investigator will tell the participant about the study and what is involved and will ask them to sign a consent form. The participant may ask as many questions as they would like before deciding about study participation.
- For each of the visits, the investigator will review questions with the participant about their health to ensure their eligibility to undergo fMRI on the day of testing.
- Also for each visit, the investigator will ask the participant to respond to a short questionnaire related to their current mood.
- In the pre-training and the post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts.
- For each of the participant's visits, they will spend 50-60 minutes either in the MRI scanner, while viewing pictures and text on a screen. During this time, pictures of the participant's brain at work and at rest will be acquired. In the training visits only, the participant will learn to increase blood flow in certain brain regions with the help of information presented to them on the screen.
- For each of the participant's visits, they will be asked to respond to a short questionnaire related to their current mood.
- In the pre-training/post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts as well as their personality. The participant will also perform brief tests related to the thinking process.
- At the end of each visit, the participant will complete a questionnaire about how they approached the study tasks and whether they experienced any discomfort in the MRI scanner or while wearing the fNIRS system.
- Upon study completion, the investigator will tell the participant about the general goals of the study and answer any questions that they may have.
The procedure can be stopped at any time.
The study will conclude with debriefing and reimbursement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior insula cortex activation | Active comparator | Behavioral: Brain activity training - anterior insulaParticipants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text. |
| Primary auditory cortex activation | Active comparator | Behavioral: Brain activity training - medial prefrontal cortexParticipants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-30 years or 63-90 years
- Right-handed
- Native English speaker
Key exclusion criteria (6 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 |
|---|---|---|
| Brain activity training - anterior insulatraining sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain | Behavioural | Anterior insula cortex activation |
| Brain activity training - medial prefrontal cortextraining sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain | Behavioural | Primary auditory cortex activation |
Primary outcome
Increased activation of anterior insula from pre-training to post-training
Time frame: Pre-training session (baseline visit); post-training session (approximately one week later)
Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
1 secondary outcome
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
Time frame: Pre-training (baseline visit); post-training visit (approximately one week later)
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 22 Jan 2020.
- Real-Time fMRI in Neuroscience Research and Its Use in Studying the Aging BrainLink provided by the sponsor.
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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 Brain activity training - anterior insula and Brain activity training - medial prefrontal cortex in people with Aging and Emotion, 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 3 inclusion and 6 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 22 Jan 2020. 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?
Increased activation of anterior insula from pre-training to post-training (time frame: Pre-training session (baseline visit); post-training session (approximately one week later)). 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 22 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.