Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2024-03-20
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Active transcutaneous vagus nerve stimulation
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.
Transcutaneous vagus nerve stimulation
Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.
Sham transcutaneous vagus nerve stimulation
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.
Transcutaneous vagus nerve stimulation
Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.
Closed-loop AM-tACS increase frontal midline theta oscillation
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.
Closed-loop AM-tACS
Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.
Closed-loop AM-tACS decrease frontal midline theta oscillation
Equivalent to the active comparator - except here the target oscillation will be suppressed.
Closed-loop AM-tACS
Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.
Interventions
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Transcutaneous vagus nerve stimulation
Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.
Closed-loop AM-tACS
Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.
Eligibility Criteria
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Inclusion Criteria
* abstinence between 3 days and 12 months
Exclusion Criteria
* neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis)
* current severe major depressive disorder, manic episode or schizophreniform disorder
* intake of anticonvulsive or high-potency antipsychotic medication
18 Years
70 Years
ALL
No
Sponsors
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Medical School Berlin
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Anne Beck
Prof. Dr. Anne Beck
Principal Investigators
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Anne Beck, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
Nina Romanczuk-Seiferth, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany
Surjo Soekadar, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany
Locations
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Charité - Berlin University of Medicine
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Rosenthal
Role: primary
References
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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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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TRR265 C02 FP2
Identifier Type: -
Identifier Source: org_study_id
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