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Clinical Trials/NCT05913518
NCT05913518
Recruiting
Not Applicable

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

Brugmann University Hospital1 site in 1 country130 target enrollmentMay 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Brugmann University Hospital
Enrollment
130
Locations
1
Primary Endpoint
Event related potential
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2019
End Date
June 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Salvatore Campanella

FNRS Research Director

Brugmann University Hospital

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.

Outcomes

Primary Outcomes

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: 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(Immediately after the last neurofeedback training session T1)
  • Reaction times(Baseline T0)
  • Abstinence(3 months post discharge)

Study Sites (1)

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