Trial document





This trial has been registered retrospectively.
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  DRKS00010253

Trial Description

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Title

Realtime fMRI Neurofeedback in the Treatment of Alcohol Use Disorder

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Trial Acronym

SyBil-AA Neurofeedback

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URL of the Trial

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Brief Summary in Lay Language

Many humans with alcohol dependency feel physical reactions or an urge to drink when they are confronted with stimuli like pictures or the smell of alcohol. In this study the brain processes involved are going to be made visible to allow participants to gain voluntary control over them and become potentially more resilient against relapses. For this “neurofeedback” alcohol dependent participants after clinical withdrawal will be presented pictures of alcoholic beverages while simultaneously brain processes measured by functional magnetic resonance tomography will be displayed and fed back. At the same time, the participants have the task to influence the displayed process in a specified direction. A total of 3 sessions of approximately 1.5 hours will be conducted, with the neurofeedback task taking approximately 30 minutes per session. Within the study, participant will be assigned to different groups that receive feedback from different brain processes. The goal of the study is to test whether brain processes change during neurofeedback training, whether these changes differ between groups, and whether relapse rates are different between the groups.

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Brief Summary in Scientific Language

The research objective of the study is to evaluate neural cue-reactivity to alcohol cues and the ability of alcohol dependent subjects to modulate this response and to test whether such modulation effects relapse rates. For this goal we will apply real-time functional magnetic resonance imaging (fMRI) neurofeedback (rtNF) to alcohol dependent in- and outpatients at the Department of Addictive Behaviour and Addiction Medicine of the Central Institute of Mental Health. fMRI will be used to report the neural activity of specific, topographically closely defined brain areas or the connectivity between such areas, almost in real time to the participant, allowing them to learn controlling responses to alcohol stimuli and change neural activation and connectivity signatures associated with relapse. Neurofeedback training will be carried out while presenting alcohol cues (images of the favorite beverages) to the patients. Three training sessions with a duration of approximately 30 minutes of neurofeedback will be conducted within a maximum of two weeks. The patients will be randomly assigned to one of 5 neurofeedback groups (ventral striatum downregulation (VS), inferior frontal gyrus upregulation (IFG), VS-IFG connectivity negative regulation, control region upregulation, control region downregulation) and be blind to the condition. To test the effect of the rtNF feedback on brain connectivity pattern and on cue reactivity related information processing, also resting state fMRI scans will be conducted at the training sessions. Relapse rates after 3 months and functional changes in the brain during and over the training sessions will be assessed and used to test whether fMRI neurofeedback can influence relapse rates, which functional changes in the brain are associated with the intervention, and whether these effects differ between the treatment groups.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010253
  •   2016/05/10
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  •   yes
  •   Approved
  •   2015-613N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1181-4218 
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Health Condition or Problem studied

  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   fMRI neurofeedback control region upregulation while presenting alcohol cues (images of the favorite beverages) to the patients, 3 sessions à ca. 30 min within a maximum of two weeks.
  •   fMRI neurofeedback control region downregulation while presenting alcohol cues (images of the favorite beverages) to the patients, 3 sessions à ca. 30 min within a maximum of two weeks.
  •   fMRI neurofeedback ventral striatum (VS) downregulation while presenting alcohol cues (images of the favorite beverages) to the patients, 3 sessions à ca. 30 min within a maximum of two weeks.
  •   fMRI neurofeedback prefrontal Cortex (PFC) upregulation while presenting alcohol cues (images of the favorite beverages) to the patients, 3 sessions à ca. 30 min within a maximum of two weeks.
  •   fMRI neurofeedback PFC-VS connectivity negative regulation while presenting alcohol cues (images of the favorite beverages) to the patients, 3 sessions à ca. 30 min within a maximum of two weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of relapse after neurofeedback training:
- follow-up contacts after 1, 2 (phone interview) and 3 months (interview in the clinic) after the completion of neurofeedback Training.
-Form 90 (Structured Assessment Interview
for Drinking and Related Behaviors)
- OCDS-G (Obsessive compulsive Drinking Scale)
- CAS-A (Craving-Automatized-Scale-Alcohol)
- AASE(Alcohol Abstinence Self-Efficacy Scale)
- AUQ (Alcohol Urge Questionnaire)
-breath test and blood test (at the beginning of the interview in den clinic, after 3 months of the last neurofeedback training)


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Secondary Outcome

Functional changes (activation and connectivity) in the brain over the sessions assessed with magnetic resonance Imaging.

Changes in alcohol craving during the sessions assessed by a visual analogue scale.

Predicitive power of magnetic resonance Imaging for learning neurofeedback and for the success of the intervention.

Differences in effectivity of the group-specific interventions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/30
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

-Gender: Both, male and female
-Age: 18 and 65 years
-Normal or corrected to normal vision with best corrected visual acuity ( > 0,8, Landolt C rings)
-appropriate comprehension of the German language
-written informed consent
-Alcohol use disorder according to DSM-IV and ICD-10
-abstinent for 5-28 days at first assessment, finished alcohol detoxification

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Exclusion Criteria

-Axis I mental disorders (SCID-I) during the last 12 months except (for patients) abuse and dependence of alcohol and
nicotine
-neurological disorders
-epilepsy
-exclusion criteria for MRT (pace maker, implanted metal or pregnancy)
-positive drug screening
-any current psychoactive medication for the last 3 days before study entry
-suicidal tendencies

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Addresses

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    • Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Mr.  Prof. Dr. med.  Falk  Kiefer 
    • J5
    • 68159  Mannheim
    • Germany
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    • Abteilung für Klinische Psychologie, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Mr.  Prof. Dr.  Peter  Kirsch 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Nathalie  Bahs 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Europäische Kommission Generaldirektion Gesundheit und Lebensmittelsicherheit
    • B – 1049  Brüssel
    • Belgium
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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