CHU Brugmann
Brussels, 1020, Belgium
Location status: Recruiting
Location contact
Clémence Dousset
SUB_INVESTIGATOR
Salvatore Campanella
CONTACT
Salvatore Campanella
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT05913518
Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Neurofeedback active
DeviceNeurofeedback 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
DeviceNeurofeedback 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 outcomes
-
Event related potential
Time frame: Baseline T0
Error related negativity (ERN) measurement
-
Event related potential
Time frame: Immediately after the last neurofeedback training session T1
Error related negativity (ERN) measurement
-
Metacognition questionnaire-30 (MCQ-30)
Time frame: Baseline T0
Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.
-
Metacognition questionnaire-30 (MCQ-30)
Time frame: Immediately after the last neurofeedback training session T1
Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.
Secondary outcomes
-
Commission error rate
Time frame: Baseline T0
Behavior assessment
-
Commission error rate
Time frame: Immediately after the last neurofeedback training session T1
Behavior assessment
-
Reaction times
Time frame: Baseline T0
Behavior assessment
-
Abstinence
Time frame: Immediately after the last neurofeedback training session T1
Number of days of abstinence
-
Abstinence
Time frame: 2 weeks post discharge
Number of days of abstinence
-
Abstinence
Time frame: 1 month post discharge
Number of days of abstinence
-
Abstinence
Time frame: 2 months post discharge
Number of days of abstinence
-
Abstinence
Time frame: 3 months post discharge
Number of days of abstinence
Study contacts
Contact information is provided by the study sponsor or research team.
Clémence Dousset
CONTACT
Salvatore Campanella
CONTACT
Sponsors and collaborators
Lead sponsor
Brugmann University Hospital
Other
Registry information
Official study title
Training Metacognition by Means of Neurofeedback in Subjects With Alcohol Use Disorder Induces Neural Modifications: an Event-related Potentials Study
Important dates
- Study start
- 2019
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jun 22, 2023
- Registry last updated
- Aug 6, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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