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| Name | Class |
|---|---|
| Medical School Berlin | OTHER |
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Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active transcutaneous vagus nerve stimulation | Active Comparator | The tVNS device consisted of two titan electrodes mounted on a gel frame and connected to a wired neurostimulation device (tVNS Health GmbH, Germany). Electrodes were placed on the cymba conchae. Stimulation intensity of 0.5 mA, delivered with a pulse width of 200-300 μs at 25 Hz. |
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| Sham transcutaneous vagus nerve stimulation | Sham Comparator | Stimulation parameters equivalent to active but sham stimulation was administered by positioning the electrodes on the central part of the left earlobe rather than the outer auditory canal, as the earlobe lacks vagus innervation. |
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| Closed-loop AM-tACS increase frontal midline theta oscillation | Active Comparator | We will deliver amplitude-modulated transcranial alternating current stimulation (AM-tACS) using two circular rubber electrodes (4 cm diameter) positioned at the Fpz and Cz locations of the international 10-20 system. The AM-tACS stimulation waveform features a carrier signal frequency of 10 kHz, an amplitude of ±1 mA, and a signal that is real-time synchronized with theta oscillations of the frontal midline. In the active condition target oscillations (frontal midline theta) will be increased. |
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| Closed-loop AM-tACS decrease frontal midline theta oscillation | Sham Comparator | Equivalent to the active comparator - except here the target oscillation will be suppressed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vagus nerve stimulation | Device | Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Control | Before and after the treatment, we will assess cognitive control on a behavioral (response inhibition) and neurophysiological level (electroencephalogram) using a Simon GoNogo task, which reliably triggers activation of the frontal midline regions (Swick et al., 2011). | Pre and post intervention after 6-8 weeks |
| Interoception | Additionally, interoceptive control is intended to be measured using a heartbeat detection task (Kleckner et al., 2015). | Pre and post intervention after 6-8 weeks |
| Cue-Reactivity | Evaluate physiological reactivity to alcohol cues through a passive viewing task developed based on the guidelines of Ekhitiari et al. (2022) and measure subjective cue-induced cravings. | Pre and post intervention after 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Heartrate | Heartrate change due to stimulation | pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks |
| Heartrate Variability | Heartrate variability change due to stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annika Rosenthal | Contact | 030 450 517040 | annika.rosenthal@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Anne Beck, Prof. Dr. | Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany | Principal Investigator |
| Nina Romanczuk-Seiferth, Prof. Dr. | Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Berlin University of Medicine | Recruiting | Berlin | State of Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35121856 | Background | Ekhtiari H, Zare-Bidoky M, Sangchooli A, Janes AC, Kaufman MJ, Oliver JA, Prisciandaro JJ, Wustenberg T, Anton RF, Bach P, Baldacchino A, Beck A, Bjork JM, Brewer J, Childress AR, Claus ED, Courtney KE, Ebrahimi M, Filbey FM, Ghahremani DG, Azbari PG, Goldstein RZ, Goudriaan AE, Grodin EN, Hamilton JP, Hanlon CA, Hassani-Abharian P, Heinz A, Joseph JE, Kiefer F, Zonoozi AK, Kober H, Kuplicki R, Li Q, London ED, McClernon J, Noori HR, Owens MM, Paulus MP, Perini I, Potenza M, Potvin S, Ray L, Schacht JP, Seo D, Sinha R, Smolka MN, Spanagel R, Steele VR, Stein EA, Steins-Loeber S, Tapert SF, Verdejo-Garcia A, Vollstadt-Klein S, Wetherill RR, Wilson SJ, Witkiewitz K, Yuan K, Zhang X, Zilverstand A. A methodological checklist for fMRI drug cue reactivity studies: development and expert consensus. Nat Protoc. 2022 Mar;17(3):567-595. doi: 10.1038/s41596-021-00649-4. Epub 2022 Feb 4. | |
| 21376819 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Closed-loop AM-tACS | Device | Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise. |
|
| pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks |
| Mindfulness | Trait and state mindfulness | pre, post after 6-8 weeks |
| Alcohol consumption | Frequency of drinking days and quantity of alcohol consumed | pre, post after 6-8 weeks, follow-up three months later |
| Dependence Severity (Alcohol Dependence Scale) | Craving, urge and dependence severity assessed via questionnaires. | pre, post after 6-8 weeks, follow-up three months later |
| Principal Investigator |
| Surjo Soekadar, Prof. Dr. | Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany | Principal Investigator |
| Background |
| Swick D, Ashley V, Turken U. Are the neural correlates of stopping and not going identical? Quantitative meta-analysis of two response inhibition tasks. Neuroimage. 2011 Jun 1;56(3):1655-65. doi: 10.1016/j.neuroimage.2011.02.070. Epub 2011 Mar 3. |
| 26265009 | Background | Kleckner IR, Wormwood JB, Simmons WK, Barrett LF, Quigley KS. Methodological recommendations for a heartbeat detection-based measure of interoceptive sensitivity. Psychophysiology. 2015 Nov;52(11):1432-40. doi: 10.1111/psyp.12503. Epub 2015 Aug 12. |
| 39334026 | Derived | Rosenthal A, Haslacher D, Garbusow M, Pangratz L, Apfel B, Soekadar S, Romanczuk-Seiferth N, Beck A. Neuromodulation and mindfulness as therapeutic treatment in detoxified patients with alcohol use disorder. BMC Psychiatry. 2024 Sep 27;24(1):635. doi: 10.1186/s12888-024-06085-4. |