Brain Training for Substance Use Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

• Change in Rating of Cue Reactivity (1-5 Likert Scale) [Срок оценки: 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) [Срок оценки: Pre- to post-biofeedback session (same day, approximately 30 minutes)]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Minnesota - Department of Psychiatry & Behavioral Health — Minneapolis

Идентификаторы

NCT: NCT06870110 · Pro00071720 · R43DA057773-01A1 · R44DA059517-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗