search
Back to results

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

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Neurofeedback active
Neurofeedback placebo
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU BrugmannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Active neurofeedback group

Placebo feedback group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Event related potential
Error related negativity (ERN) measurement
Event related potential
Error related negativity (ERN) measurement
Metacognition questionnaire-30 (MCQ-30)
Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.
Metacognition questionnaire-30 (MCQ-30)
Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.

Secondary Outcome Measures

Commission error rate
Behavior assessment
Commission error rate
Behavior assessment
Reaction times
Behavior assessment
Abstinence
Number of days of abstinence
Abstinence
Number of days of abstinence
Abstinence
Number of days of abstinence
Abstinence
Number of days of abstinence
Abstinence
Number of days of abstinence

Full Information

First Posted
June 1, 2023
Last Updated
July 26, 2023
Sponsor
Brugmann University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05913518
Brief Title
Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study
Official Title
Training Metacognition by Means of Neurofeedback in Subjects With Alcohol Use Disorder Induces Neural Modifications: an Event-related Potentials Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active neurofeedback group
Arm Type
Experimental
Arm Title
Placebo feedback group
Arm Type
Placebo Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Neurofeedback active
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Neurofeedback placebo
Intervention Description
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 Measure Information:
Title
Event related potential
Description
Error related negativity (ERN) measurement
Time Frame
Baseline T0
Title
Event related potential
Description
Error related negativity (ERN) measurement
Time Frame
Immediately after the last neurofeedback training session T1
Title
Metacognition questionnaire-30 (MCQ-30)
Description
Metacognitive assessment by means of a questionnaire. Scores from 6 to 24, with higher scores meaning worse outcomes.
Time Frame
Baseline T0
Title
Metacognition questionnaire-30 (MCQ-30)
Description
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 Outcome Measure Information:
Title
Commission error rate
Description
Behavior assessment
Time Frame
Baseline T0
Title
Commission error rate
Description
Behavior assessment
Time Frame
Immediately after the last neurofeedback training session T1
Title
Reaction times
Description
Behavior assessment
Time Frame
Baseline T0
Title
Abstinence
Description
Number of days of abstinence
Time Frame
Immediately after the last neurofeedback training session T1
Title
Abstinence
Description
Number of days of abstinence
Time Frame
2 weeks post discharge
Title
Abstinence
Description
Number of days of abstinence
Time Frame
1 month post discharge
Title
Abstinence
Description
Number of days of abstinence
Time Frame
2 months post discharge
Title
Abstinence
Description
Number of days of abstinence
Time Frame
3 months post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvatore Campanella
Phone
3224772705
Email
salvatore.campanella@chu-brugmann.be
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Dousset
Email
clemence.dousset@ulb.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Campanella
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Campanella
Phone
3224772705
Email
salvatore.campanella@chu-brugmann.be
First Name & Middle Initial & Last Name & Degree
Salvatore Campanella
First Name & Middle Initial & Last Name & Degree
Clémence Dousset

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs