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Recruiting NCT05913518

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

No phase Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurofeedback active, Neurofeedback placebo.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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).
  • 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

Primary outcome measures

  • Event related potential [Time frame: Baseline T0]
  • Event related potential [Time frame: Immediately after the last neurofeedback training session T1]
  • Metacognition questionnaire-30 (MCQ-30) [Time frame: Baseline T0]
  • Metacognition questionnaire-30 (MCQ-30) [Time frame: Immediately after the last neurofeedback training session T1]
Secondary outcome measures (8)
  • Commission error rate [Time frame: Baseline T0]
  • Commission error rate [Time frame: Immediately after the last neurofeedback training session T1]
  • Reaction times [Time frame: Baseline T0]
  • Abstinence [Time frame: Immediately after the last neurofeedback training session T1]
  • Abstinence [Time frame: 2 weeks post discharge]
  • Abstinence [Time frame: 1 month post discharge]
  • Abstinence [Time frame: 2 months post discharge]
  • Abstinence [Time frame: 3 months post discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Belgium · 1 center
  • CHU Brugmann — Brussels

Identifiers

NCT: NCT05913518 · Neurofeedback

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗