NCT05913518

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

6.1 years

First QC Date

June 1, 2023

Last Update Submit

August 5, 2024

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (4)

  • Event related potential

    Error related negativity (ERN) measurement

    Baseline T0

  • Event related potential

    Error related negativity (ERN) measurement

    Immediately after the last neurofeedback training session T1

  • Metacognition questionnaire-30 (MCQ-30)

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

    Baseline T0

  • Metacognition questionnaire-30 (MCQ-30)

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

    Immediately after the last neurofeedback training session T1

Secondary Outcomes (8)

  • Commission error rate

    Baseline T0

  • Commission error rate

    Immediately after the last neurofeedback training session T1

  • Reaction times

    Baseline T0

  • Abstinence

    Immediately after the last neurofeedback training session T1

  • Abstinence

    2 weeks post discharge

  • +3 more secondary outcomes

Study Arms (3)

Active neurofeedback group

EXPERIMENTAL
Device: Neurofeedback active

Placebo feedback group

PLACEBO COMPARATOR
Device: Neurofeedback placebo

Control group

NO INTERVENTION

Interventions

Neurofeedback activeDEVICE

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).

Active neurofeedback group
Neurofeedback placeboDEVICE

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

Placebo feedback group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • history of neurological disorders
  • other serious medical conditions
  • neuroleptic treatment are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Salvatore Campanella

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvatore Campanella

CONTACT

3224772705salvatore.campanella@chu-brugmann.be

Clémence Dousset

CONTACT

clemence.dousset@ulb.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FNRS Research Director

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 22, 2023

Study Start

May 14, 2019

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)