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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Device: Neurofeedback placebo; Device: Neurofeedback active

• Registration Number: NCT05913518
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo feedback group	Neurofeedback placebo	-
Active neurofeedback group	Neurofeedback active	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Commission error rate	Immediately after the last neurofeedback training session T1	Behavior assessment
Reaction times	Baseline T0	Behavior assessment
Abstinence	3 months post discharge	Number of days of abstinence

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium