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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrugmann University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

history of neurological disorders

other serious medical conditions

neuroleptic treatment are excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neurofeedback active

    Device

    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

    Device

    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

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: Active neurofeedback groupExperimental treatment 1 intervention
Group B: Placebo feedback groupPlacebo comparator 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Event related potential

Error related negativity (ERN) measurement

Time frame
Baseline T0
2

Event related potential

Error related negativity (ERN) measurement

Time frame
Immediately after the last neurofeedback training session T1
3

Metacognition questionnaire-30 (MCQ-30)

Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.

Time frame
Baseline T0
4

Metacognition questionnaire-30 (MCQ-30)

Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.

Time frame
Immediately after the last neurofeedback training session T1

Secondary outcomes

1

Commission error rate

Behavior assessment

Time frame
Baseline T0
2

Commission error rate

Behavior assessment

Time frame
Immediately after the last neurofeedback training session T1
3

Reaction times

Behavior assessment

Time frame
Baseline T0
4

Abstinence

Number of days of abstinence

Time frame
Immediately after the last neurofeedback training session T1

Other outcomes

Sponsors and contacts

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