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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913518
• Other study ID #: Neurofeedback
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: Brugmann University Hospital
• Contact: Salvatore Campanella
• Phone: 3224772705
• Email: salvatore.campanella[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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).
• 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

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event related potential	Error related negativity (ERN) measurement	Baseline T0
Primary	Event related potential	Error related negativity (ERN) measurement	Immediately after the last neurofeedback training session T1
Primary	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
Primary	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	Commission error rate	Behavior assessment	Baseline T0
Secondary	Commission error rate	Behavior assessment	Immediately after the last neurofeedback training session T1
Secondary	Reaction times	Behavior assessment	Baseline T0
Secondary	Abstinence	Number of days of abstinence	Immediately after the last neurofeedback training session T1
Secondary	Abstinence	Number of days of abstinence	2 weeks post discharge
Secondary	Abstinence	Number of days of abstinence	1 month post discharge
Secondary	Abstinence	Number of days of abstinence	2 months post discharge
Secondary	Abstinence	Number of days of abstinence	3 months post discharge