Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study

Study Overview
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Brief Summary
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Addressing cognitive deficits in alcohol use disorder (AUD) supports recovery. Impaired metacognitive functioning in AUD causes compromised recognition of the interoceptive state leading to the maintenance of alcohol abuse despite negative consequences. By promoting greater self-awareness and self-regulation, neurofeedback training is of high relevance in metacognition remediation to support abstinence. The main objective of the present study is to validate neurofeedback as a complementary clinical tool to overcome metacognitive deficits that represent a significant factor in the maintenance of harmful consumption behavior and relapse phenomena in AUD.

Official Title
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Training Metacognition by Means of Neurofeedback in Subjects With Alcohol Use Disorder Induces Neural Modifications: an Event-related Potentials Study

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: Neurofeedback active
* Device: Neurofeedback placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 65 years old undergoing a 3- to 4-week detoxification treatment program at the Alcohol Unit of CHU Brugmann hospital (Brussels, BELGIUM), who have been diagnosed with severe AUD (alcohol use disorder) according to the DSM-V-TR. Exclusion Criteria: history of neurological disorders other serious medical conditions neuroleptic treatment are excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active neurofeedback group<br> | Device: Neurofeedback active<br>* Neurofeedback uses real-time displays of brain activity to teach self regulation of brain function. People can learn to control their own brain activity through operant conditioning, where they receive feedback on their brainwaves and learn to modify them to achieve a desired state. Active neurofeedback group aims at enhancing the sensorimotor rhythm (12-15 Hz).<br>|
| Placebo Comparator: Placebo feedback group<br> | Device: Neurofeedback placebo<br>* Neurofeedback uses real-time displays of brain activity to teach self regulation of brain function. People can learn to control their own brain activity through operant conditioning, where they receive feedback on their brainwaves and learn to modify them to achieve a desired state. Placebo feedback group (PFT) : patients enhance random frequency bands<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event related potential | Error related negativity (ERN) measurement | Baseline T0 | 
| Event related potential | Error related negativity (ERN) measurement | Immediately after the last neurofeedback training session T1 | 
| Metacognition questionnaire-30 (MCQ-30) | Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes. | Baseline T0 | 
| Metacognition questionnaire-30 (MCQ-30) | Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes. | Immediately after the last neurofeedback training session T1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Commission error rate | Behavior assessment | Baseline T0 | 
| Commission error rate | Behavior assessment | Immediately after the last neurofeedback training session T1 | 
| Reaction times | Behavior assessment | Baseline T0 | 
| Abstinence | Number of days of abstinence | Immediately after the last neurofeedback training session T1 | 
| Abstinence | Number of days of abstinence | 2 weeks post discharge | 
| Abstinence | Number of days of abstinence | 1 month post discharge | 
| Abstinence | Number of days of abstinence | 2 months post discharge | 
| Abstinence | Number of days of abstinence | 3 months post discharge |