The SyBil-AA real-time fMRI neurofeedback study: protocol of a single-blind randomized controlled trial in alcohol use disorder

Abstract

BackgroundAlcohol Use Disorder is a highly prevalent mental disorder which puts a severe burden on individuals, families, and society. The treatment of Alcohol Use Disorder is challenging and novel and innovative treatment approaches are needed to expand treatment options. A promising neuroscience-based intervention method that allows targeting cortical as well as subcortical brain processes is real-time functional magnetic resonance imaging neurofeedback. However, the efficacy of this technique as an add-on treatment of Alcohol Use Disorder in a clinical setting is hitherto unclear and will be assessed in the Systems Biology of Alcohol Addiction (SyBil-AA) neurofeedback study.MethodsN = 100 patients with Alcohol Use Disorder will be randomized to 5 parallel groups in a single-blind fashion and receive real-time functional magnetic resonance imaging neurofeedback while they are presented pictures of alcoholic beverages. The groups will either downregulate the ventral striatum, upregulate the right inferior frontal gyrus, negatively modulate the connectivity between these regions, upregulate, or downregulate the auditory cortex as a control region. After receiving 3 sessions of neurofeedback training within a maximum of 2 weeks, participants will be followed up monthly for a period of 3 months and relapse rates will be assessed as the primary outcome measure.DiscussionThe results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback training in the treatment of Alcohol Use Disorder as well as in the involved brain systems. This might help to identify predictors of successful neurofeedback treatment which could potentially be useful in developing personalized treatment approaches.Trial registrationThe study was retrospectively registered in the German Clinical Trials Register (trial identifier: DRKS00010253; WHO Universal Trial Number (UTN): U1111–1181-4218) on May 10th, 2016.

A systematic review of fMRI neurofeedback reporting and effects in clinical populations

“…2 ). 10 of 41 trials already have published results (see Table 2 ) and two trials have corresponding trial design publications ( Cox et al, 2016 , Gerchen et al, 2018 ). All published results of trials have a corresponding entry in one of the two international trial databases included in the search protocol.…”

“…One of the published trials has also been registered in a national database. One trial design has only been registered in a national database ( Gerchen et al, 2018 ).…”

Neurofeedback: Principles, appraisal, and outstanding issues

“…Neurofeedback has been used in a range of cognitive (Gruzelier, ), psychiatric (Fovet, Jardri, & Linden, ; Marzbani et al., ) and neurological conditions (Marzbani et al., ), including emotion regulation (Bruehl et al., ; Jacob, Or‐Borichev, Jackont, Lubianiker, & Hendler, ; Johnston, Boehm, Healy, Goebel, & Linden, ; Keynan et al., ; Micoulaud‐Franchi, Fakra, Cermolacce, & Vion‐Dury, ; Zotev, Phillips, Young, Drevets, & Bodurka, ), attention‐deficit hyperactivity disorder (ADHD; Gevensleben, Rothenberger, Moll, & Heinrich, ; Micoulaud‐Franchi, Geoffroy, et al., ; Schönenberg et al., ; Sonuga‐Barke et al., ; Strehl et al., ; Vollebregt, van Dongen‐Boomsma, Buitelaar, & Slaats‐Willemse, ), autism (Coben, Linden, & Myers, ; Friedrich et al., ; LaMarca, Gevirtz, Lincoln, & Pineda, ; Pineda, Carrasco, Datko, Pillen, & Schalles, ), depression (Linden et al., ; Young et al., ; Zotev et al., ), schizophrenia (Dyck et al., ; Surmeli, Ertem, Eralp, & Kos, ), addictions (Arani, Rostami, & Nostratabadi, ; Gerchen et al., ; Scott, Kaiser, Othmer, & Sideroff, ; Unterrainer, Lewis, & Gruzelier, ), eating disorders (Lackner et al., ), post‐traumatic stress disorder (Kluetsch et al., ), epilepsy (Micoulaud‐Franchi, Lanteaume, Pallanca, Vion‐Dury, & Bartolomei, ; Sterman, ; Strehl, Birkle, Wörz, & Kotchoubey, ; Strehl, Kotchoubey, Trevorrow, & Birbaumer, ; Tan et al., ), stroke (Mihara et al., ; Rozelle & Budzynski, ; Wang, Mantini, & Gillebert, ), visuo‐spatial neglect (Robineau et al., ), traumatic brain injury (Bennett et al., ; May, Benson, Balon, & Boutros, ; Munivenkatappa, Rajeswaran, Indira Devi, Bennet, & Upadhyay, ; Thornton & Carmody, ), motor rehabilitation (Linden & Turner, ), pain (deCharms et al., ), tinnitus (Güntensperger, Thüring, Meyer, Neff, & Kleinjung, ), and insomnia (Cortoos, De Valck, Arns, Bret...…”

The NeMo real-time fMRI neurofeedback study: protocol of a randomised controlled clinical intervention trial in the neural foundations of mother–infant bonding

“…For calculation of the feedback signal, the ROI intensity value of the last three volumes is averaged and compared with the average intensity of the baseline condition. For further technical details regarding the NFB setup, please refer to Gerchen et al 91 which uses an identical NFB procedure in the context of alcohol addiction.…”