Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-17
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Biofeedback
Bias Modification Biofeedback
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.
Interventions
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Bias Modification Biofeedback
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted into chemical treatment with opioid use being a reason for treatment;
* DSM-IV-TR diagnosis of OUD;
* Ability to provide informed consent;
* A minimum of a 6th grade reading level; and
* Able and willing to provide own contact information for follow-up visit(s).
Control participants:
* Age- and gender-matched to an OUD patient participant in the study;
* Ability to provide informed consent;
* A minimum of a 6th grade reading level;
* Able and willing to provide own contact information for follow-up visit(s).
Exclusion Criteria
* Refusal or inability to consent;
* Pregnant;
* History of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures not caused by withdrawal from substances, Other \[please specify\]);
* Inability to see text and photos clearly on the computer display; and
* Unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary.
Control participants:
* Refusal or inability to consent;
* Pregnant;
* History of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures, Other \[please specify\]);
* Inability to see text and photos clearly on the computer display;
* Current or previous problems using opioids, other prescription (prescribed or not prescribed) or illicit drugs;
* Regular nicotine user (e.g., cigarette smoker, e-cig user) within the past 12 months; and
* Unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Neurotype Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Justin Anker, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Scott Burwell, PhD
Role: STUDY_DIRECTOR
Neurotype Inc.
Locations
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University of Minnesota - Department of Psychiatry & Behavioral Health
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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