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