Emotion Study -- A Neurofeedback Approach

Aging Clinical Trial

Official title:

Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194907
• Other study ID #: IRB201300814 closed
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 8, 2020

Study information

• Verified date: January 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Emotion

Intervention

Behavioral:
• Brain activity training - anterior insula
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 cortex
training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-training session (baseline visit); post-training session (approximately one week later)
Secondary	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.	Pre-training (baseline visit); post-training visit (approximately one week later)

External Links

•   Real-Time fMRI in Neuroscience Research and Its Use in Studying the Aging Brain