Neuromodulation and Mindfulness Patients With AUD
- Conditions
- Alcohol Dependence
- Interventions
- Device: Transcutaneous vagus nerve stimulationDevice: Closed-loop AM-tACS
- Registration Number
- NCT06308484
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Alcohol Dependence (ICD-10)
- abstinence between 3 days and 12 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham transcutaneous vagus nerve stimulation 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. Active transcutaneous vagus nerve stimulation 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. Closed-loop AM-tACS decrease frontal midline theta oscillation Closed-loop AM-tACS Equivalent to the active comparator - except here the target oscillation will be suppressed. Closed-loop AM-tACS increase frontal midline theta oscillation Closed-loop AM-tACS 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.
- Primary Outcome Measures
Name Time Method Cue-Reactivity 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 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 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).
- Secondary Outcome Measures
Name Time Method Heartrate pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks Heartrate change due to stimulation
Alcohol consumption pre, post after 6-8 weeks, follow-up three months later Frequency of drinking days and quantity of alcohol consumed
Heartrate Variability pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks Heartrate variability change due to stimulation
Mindfulness pre, post after 6-8 weeks Trait and state mindfulness
Dependence Severity (Alcohol Dependence Scale) pre, post after 6-8 weeks, follow-up three months later Craving, urge and dependence severity assessed via questionnaires.
Trial Locations
- Locations (1)
Charité - Berlin University of Medicine
🇩🇪Berlin, Germany