- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801254
Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior
April 29, 2015 updated by: Jordan Silberman, University of Rochester
The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control; however, researchers have not yet harnessed neuroeconomics findings to develop interventions for improving self-control ability.
The investigators are currently developing such an intervention.
The investigators' approach involves using a brain-computer interface with audiovisual feedback to show people what is happening in their own brains, in real time.
Through this interface, individuals are trained to increase levels of neural activity that may facilitate self-control, which, in turn, may improve the ability to exhibit self-controlled behaviors.
This may increase the ability to engage in heath behaviors for which self-control is required (eg, dieting and exercising).
The investigators' long-term goal is to create a tool that will help people develop the self-control needed to achieve lasting improvements in health behaviors.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14627
- University of Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Can read and write fluently in English
- At least 18 years of age
- Right-handed
- Overweight or obese (BMI > 24.9)
- Currently has a University of Rochester meal plan
- Currently in contemplation or action stages of change with respect to weight loss (measured with the Weight Stages of Change Algorithm; Rossi, Rossi, Velicer, & Prochaska, 1995).
Exclusion Criteria:
- History of diabetes, epilepsy, celiac disease, lactose intolerance, food allergies, veganism, mental illness, or eating disorders
- Currently taking a medication that may have a strong effect on EEG recordings (eg, an antidepressant, stimulant medication, etc.)
- Currently drinks more than 3 cups of coffee per day or roughly equivalent caffeine intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STRIDES
Brain-computer interface training protocol designed to up-regulate specific types of neural activity in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally.
Targeted neural activity types are positively associated with self-controlled behavior.
|
Self-Control TRaining for Increasing Delay of gratification through EEG operant conditioning with Source localization (STRIDES).
Brain-computer interface training protocol designed to up-regulate specific types of neural activity, in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally.
Targeted neural activity types are positively associated with self-controlled behavior.
|
Sham Comparator: Sham Control
Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior.
Stimuli used and durations of training sessions for this protocol are identical to those used in the treatment condition.
|
Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postprandial blood glucose and triglycerides
Time Frame: 4 times per week for 4 weeks
|
4 times per week for 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jordan Silberman, PhD, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
February 26, 2013
First Submitted That Met QC Criteria
February 27, 2013
First Posted (Estimate)
February 28, 2013
Study Record Updates
Last Update Posted (Estimate)
April 30, 2015
Last Update Submitted That Met QC Criteria
April 29, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSRB00043988
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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