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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: Neurofeedback active; Device: Neurofeedback placebo

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Campanella; Phone Number: 3224772705; Email: salvatore.campanella@chu-brugmann.be
• Study Contact Backup: Name: Clémence Dousset; Email: clemence.dousset@ulb.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Principal Investigator: Salvatore Campanella
    • Contact: Salvatore Campanella; Phone Number: 3224772705; Email: salvatore.campanella@chu-brugmann.be
    • Sub-Investigator: Clémence Dousset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Active neurofeedback group	Device: Neurofeedback active; 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).
Placebo Comparator: Placebo feedback group	Device: Neurofeedback placebo; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Salvatore Campanella, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: Neurofeedback

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No