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Emotion Study -- A Neurofeedback Approach

This study is currently recruiting participants.
Verified June 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT02194907
First Posted: July 18, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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.

Condition Intervention
Aging Emotion Device: Functional Magnetic Resonance Imaging

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) ]
    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.


Estimated Enrollment: 500
Study Start Date: October 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anterior insula cortex activation

Experimental - Device: Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior insula cortex.

The anterior insula is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing.

Device: Functional Magnetic Resonance Imaging
Participants in each group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior insula cortex (experimental group) or primary auditory cortex (placebo comparator).
Other Name: 3.0 Tesla, 32-channel Philips whole-body human MR scanner
Primary auditory cortex activation
Placebo - Device: 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).
Device: Functional Magnetic Resonance Imaging
Participants in each group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior insula cortex (experimental group) or primary auditory cortex (placebo comparator).
Other Name: 3.0 Tesla, 32-channel Philips whole-body human MR scanner

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 Philips 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All participants will be recruited through participant registries (IRB #131-2002; IRB #415-2007; IRB #133-2013), HealthStreet (IRB #265-2011) and distribution of handouts and flyers throughout town.
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194907


Contacts
Contact: Natalie Ebner, PhD 203-691-0371 natalie.ebner@ufl.edu
Contact: Marilyn Horta, BS 305-484-0716 mhorta09@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611-2250
Contact: Natalie Ebner, PhD    203-691-0371    natalie.ebner@ufl.edu   
Principal Investigator: Natalie Ebner, PhD         
Sub-Investigator: Ranganatha Sitaram, PhD         
Sub-Investigator: Ronald Cohen, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Natalie Ebner, PhD University of Florida, Department of Psychology
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02194907     History of Changes
Other Study ID Numbers: 201300814
First Submitted: July 10, 2014
First Posted: July 18, 2014
Last Update Posted: October 12, 2017
Last Verified: June 2017

Keywords provided by University of Florida:
Emotional Aging
Neurofeedback