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| ID | Type | Description | Link |
|---|---|---|---|
| R43DA057773-01A1 | U.S. NIH Grant/Contract | View source | |
| R44DA059517-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.
The main purpose of this project is to gather pilot data on neurofeedback games that use electroencephalogram (EEG)-based Attention Bias Modification (ABM) to reduce cue-induced drug craving processes in individuals with Opioid Use Disorder (OUD). The project will involve the use of three empirically-supported and potentially therapeutic games that include drug- (such as pill bottle and syringe) and non-drug-related stimuli (such as food and smiling faces). An EEG system will be used to monitor brain activity during gameplay.
The neurofeedback loop for attention training will be synchronized to cue presentations using EEGs which monitor visual Event-Related Potentials (ERP) signatures of attention. The degree of difficulty (i.e., cue content) on subsequent trials of the game will be determined based on the level of attention measured in the neurofeedback loop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bias Modification Biofeedback | Device | The device uses EEG-based bias modification biofeedback intended to reduce attention to drug-related cues and increase attention to non-drug pleasant scenes. Specifically, the device measures perceptual biases from Event-Related Potential biomarkers related to Substance Use Disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ERP-Based Classification of Opioid-Related Attention Bias (Probability Score) | The primary outcome will be the change in ERP-based classification scores (probability values) reflecting opioid-related attention bias. ERP voltages from all electrodes will be classified with coefficients reflecting increased amplitude in Early Posterior Negativity (150 to 300 ms), P300 complex (250 to 450 ms), and Late Positive Potential (400 to 900 ms) windows. Change in classification score from the last minus first block will be evaluated. | Pre- to post-biofeedback session (same day, approximately 30 minutes) |
| Change in Visual Probe Task Reaction Time (milliseconds) to Drug-Related Stimuli | The primary outcome will be the change in reaction time (milliseconds) on the Visual Probe Task, measuring attention bias toward drug-related versus neutral stimuli. Participants will complete the task before and after the biofeedback session. Attention bias is indicated by differences in reaction time when responding to probes replacing drug-related versus neutral stimuli. Improvement is reflected by reduced bias scores, calculated as the difference between reaction times to drug-related versus neutral probes. Change scores from pre- to post-session will be analyzed. | Pre- to post-biofeedback session (same day, approximately 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rating of Cue Reactivity (1-5 Likert Scale) | The outcome will be the change in self-reported cue reactivity, measured with a Likert scale ranging from 1 (not at all) to 5 (extremely). Participants rate their cue reactivity before and after each series of images being presented for a given scene. The average change in cue reactivity across all scenes during the 30-minute biofeedback protocol will be quantified for each session. |
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Inclusion Criteria:
OUD patient participants:
Control participants:
Exclusion Criteria:
OUD patient participants:
Control participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott Burwell, PhD | Contact | 612-790-9304 | burwell@umn.edu | |
| Scott Burwell, PhD | Contact | 651-421-1696 | scott@neurotype.io |
| Name | Affiliation | Role |
|---|---|---|
| Justin Anker, PhD | University of Minnesota | Principal Investigator |
| Scott Burwell, PhD | Neurotype Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota - Department of Psychiatry & Behavioral Health | Recruiting | Minneapolis | Minnesota | 55454 | United States |
De-identified data may be shared upon request based on decision of study leadership.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| D019966 | Substance-Related Disorders |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| Pre- to post-biofeedback for a given scene (same day, approximately 30 seconds) |
| Change in Visual Analog Scale (VAS) Rating of Instantaneous Opioid Craving (1-100) | The outcome will be the change in self-reported instantaneous ("right now") opioid craving, measured with a Visual Analog Scale (VAS) ranging from 1 ("No Drug Craving") to 100 ("Extreme Drug Craving"). Participants will rate their current craving before and after the biofeedback session. Change scores from pre- to post-session will be analyzed. | Pre- to post-biofeedback session (same day, approximately 30 minutes) |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |