Recruiting

Brain Training

Sponsor:

Neurotype Inc.

Code:

NCT06870110

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Bias Modification Biofeedback

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Study ID

NCT06870110

Start date

Jan 17, 2025

Status verified date

Mar, 2025

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

OUD patient participants:

  • 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:

OUD patient 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 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Biofeedback

Interventions

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.

Primary outcome measure

  • Change in ERP-Based Classification of Opioid-Related Attention Bias (Probability Score) [ Time Frame: Pre- to post-biofeedback session (same day, approximately 30 minutes) ]
  • Change in Visual Probe Task Reaction Time (milliseconds) to Drug-Related Stimuli [ Time Frame: Pre- to post-biofeedback session (same day, approximately 30 minutes) ]

Central Contacts and Locations

Central contacts

Scott Burwell, PhD

612-790-9304burwell@umn.edu

Scott Burwell, PhD

651-421-1696scott@neurotype.io

Locations

University of Minnesota - Department of Psychiatry & Behavioral Health

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Scott Burwell, PhD

612-790-9304burwell@umn.edu

Justin Anker, PhD

612-273-9819anke0022@umn.edu

Principal Investigator:

Justin Anker, PhD

More Information

Sponsor

Neurotype Inc.

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

  • biofeedback
  • neurofeedback
  • electroencephalogram
  • addiction
  • substance use disorder
  • opioid use disorder
  • attention
  • emotion regulation
  • event-related potential

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurotype Inc. on 2025-03-11.