School of Medicine, Cardiff University
Cardiff, Wales, CF14 4XN, United Kingdom
NCT Number: NCT02486900
The study aims to examine whether the neurofeedback method (based on functional magnetic resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges to drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence and drinking behaviour will be evaluated based on the comparison between a group of patients receiving multiple sessions of neurofeedback training and a group of patients receiving treatment as usual over the same period of time.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cardiff, Wales, CF14 4XN, United Kingdom
Neurofeedback is a non-invasive neuroscientific tool in which participants receive real-time feedback about their brain activity while undergoing functional magnetic resonance imaging. Previous research has shown that participants can successfully use the feedback to self-regulate their brain responses. In this study patients who have successfully completed a detoxification programme will be trained to down-regulate/upregulate responses of motivational brain regions that are activated during exposure to alcohol/life goal-related stimuli (pictures of alcoholic drinks/life goals related). The investigators hypothesise that learning to self-regulate these neural responses will enable patients to better control craving responses to environmental alcohol cues after detoxification treatment. Patients in the intervention group will undergo 6 neurofeedback training sessions, spread across 4 months. Outcomes of the training will be compared with a group of patients who will not do the neurofeedback training but receive standard treatment (e.g. support groups and medication).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During scanning patients will be exposed to picture stimuli (showing alcoholic drinks and life goals) projected on a screen behind the scanner and viewed through a mirror attached on the MRI head coil. In each session patients will be trained to down-regulate/up-regulate activation levels in brain areas that show reliable responses to the alcohol/life goals pictures in a 'localiser' scan. Self-regulation of these brain responses will then be guided by real-time feedback of alcohol/life goals-cue elicited activation, consisting of changes in the visible alcohol/life goals picture (decreasing size = successful down-regulation; increasing size = successful upregulation). Functional MRI data will be acquired in short blocks having a duration of 5-8 minutes.
Time frame: 4 months after baseline assessment/first training
Derived from the Timeline Followback Calendar.
Time frame: 4 months after baseline assessment/first training
Derived from the Timeline Followback Calendar.
Time frame: 4 months after baseline assessment/first training
Defined as 8 or more alcohol units per day/men or 6 or more units/women. Derived from the Timeline Followback Calendar.
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Time frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Cardiff University
Other
Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
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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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