Completed

EEG Operant Conditioning for Enhanced Self-Control and Healthy Behavior Promotion

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Study Aim

This phase 1 study aims to prevent unhealthy behaviors by using EEG operant conditioning to enhance self-control, with the primary outcome being the improvement in postprandial blood glucose and triglyceride levels.

What is being tested

STRIDES

+ Sham Control

Other
Who is being recruted

Behavior+13

+ Body Weight

+ Diabetes Mellitus

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 1
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Rochester
Last updated: April 30, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01801254
Principal SponsorUniversity of Rochester
Last updated: April 30, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightCardiovascular DiseasesDiabetes Mellitus, Type 2ObesityHealth Behavior

Criteria

6 inclusion criteria required to participate
At least 18 years of age
Can read and write fluently in English
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)
Show More Criteria
3 exclusion criteria prevent from participating
Currently drinks more than 3 cups of coffee per day or roughly equivalent caffeine intake
Currently taking a medication that may have a strong effect on EEG recordings (eg, an antidepressant, stimulant medication, etc.)
History of diabetes, epilepsy, celiac disease, lactose intolerance, food allergies, veganism, mental illness, or eating disorders

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

Sham
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Rochester

Rochester, United StatesOpen University of Rochester in Google Maps
CompletedOne Study Center