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CompletedNCT02194907Updated Jan 22, 2020

Emotion Study -- A Neurofeedback Approach

An interventional study of Brain activity training - anterior insula and Brain activity training - medial prefrontal cortex in Aging and Emotion, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aging
  • Emotion

Keywords

  • Emotional Aging
  • Neurofeedback
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Between the ages of 18-30 years or 63-90 years
  • Right-handed
  • Native English speaker

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Anterior insula cortex activation

    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.

    Behavioral: Brain activity training - anterior insula

  • Active comparator
    Primary auditory cortex activation

    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.

    Behavioral: Brain activity training - medial prefrontal cortex

Interventions

  • BehavioralBrain activity training - anterior insula

    training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain

  • BehavioralBrain activity training - medial prefrontal cortex

    training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Pre-training (baseline visit); post-training visit (approximately one week later)

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611-2250, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02194907
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Jul 18, 2014
Start date
Oct 2014
Primary completion
Jan 8, 2020
Completion
Jan 8, 2020
Last update
Jan 22, 2020

Study contacts

Natalie Ebner, PhD
principal investigator · University of Florida, Department of Psychology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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