Neuromodulation and Mindfulness Patients With AUD

Официальное название

Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD

Обзор

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).

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Cognitive Control [Срок оценки: Pre and post intervention after 6-8 weeks]
• Interoception [Срок оценки: Pre and post intervention after 6-8 weeks]
• Cue-Reactivity [Срок оценки: Pre and post intervention after 6-8 weeks]

Вторичные конечные точки (5)

• Heartrate [Срок оценки: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks]
• Heartrate Variability [Срок оценки: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks]
• Mindfulness [Срок оценки: pre, post after 6-8 weeks]
• Alcohol consumption [Срок оценки: pre, post after 6-8 weeks, follow-up three months later]
• Dependence Severity (Alcohol Dependence Scale) [Срок оценки: pre, post after 6-8 weeks, follow-up three months later]

Критерии участия

Критерии включения

• Alcohol Dependence (ICD-10)
• abstinence between 3 days and 12 months

Критерии исключения

• current (last 12 months) substance use disorder/dependence
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• Charité - Berlin University of Medicine — Berlin

Публикации

• 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 PMID 35121856
• 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. PMID 21376819
• 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. PMID 26265009
• 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. PMID 39334026

Идентификаторы

NCT: NCT06308484 · TRR265 C02 FP2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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