Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cue-Reactivity
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcohol Dependence (ICD-10)
- •abstinence between 3 days and 12 months
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Transcutaneous vagus nerve stimulation (Device)
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.
干预措施: Transcutaneous vagus nerve stimulation (Device)
Closed-loop AM-tACS decrease frontal midline theta oscillation
Equivalent to the active comparator - except here the target oscillation will be suppressed.
干预措施: Closed-loop AM-tACS (Device)
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.
干预措施: Closed-loop AM-tACS (Device)
结局指标
主要结局
Cue-Reactivity
时间窗: Pre and post intervention after 6-8 weeks
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.
Cognitive Control
时间窗: Pre and post intervention after 6-8 weeks
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).
Interoception
时间窗: Pre and post intervention after 6-8 weeks
Additionally, interoceptive control is intended to be measured using a heartbeat detection task (Kleckner et al., 2015).
次要结局
- Heartrate Variability(pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks)
- Mindfulness(pre, post after 6-8 weeks)
- Dependence Severity (Alcohol Dependence Scale)(pre, post after 6-8 weeks, follow-up three months later)
- Heartrate(pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks)
- Alcohol consumption(pre, post after 6-8 weeks, follow-up three months later)
研究者
Anne Beck
Prof. Dr. Anne Beck
Health and Medical University Potsdam