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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05913518
Enrollment
130
Registered
2023-06-22
Start date
2019-05-14
Completion date
2025-06-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

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.

Interventions

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).

DEVICENeurofeedback 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

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Event related potentialBaseline T0Error related negativity (ERN) measurement
Metacognition questionnaire-30 (MCQ-30)Baseline T0Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.

Secondary

MeasureTime frameDescription
Commission error rateBaseline T0Behavior assessment
Reaction timesBaseline T0Behavior assessment
AbstinenceImmediately after the last neurofeedback training session T1Number of days of abstinence

Countries

Belgium

Contacts

Primary ContactSalvatore Campanella
salvatore.campanella@chu-brugmann.be3224772705
Backup ContactClémence Dousset
clemence.dousset@ulb.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026