Neuromodulation and Mindfulness Patients With AUD

Charité University Medicine Berlin

Status: Enrolling

Conditions: Alcohol Dependence

Treatments: Device: Closed-loop AM-tACS; Device: Transcutaneous vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06308484

TRR265 C02 FP2

Details and patient eligibility

About

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).

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

Active transcutaneous vagus nerve stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous vagus nerve stimulation

Sham transcutaneous vagus nerve stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Transcutaneous vagus nerve stimulation

Closed-loop AM-tACS increase frontal midline theta oscillation

Active Comparator group

Description:

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.

Treatment:

Device: Closed-loop AM-tACS

Closed-loop AM-tACS decrease frontal midline theta oscillation

Sham Comparator group

Description:

Equivalent to the active comparator - except here the target oscillation will be suppressed.

Treatment:

Device: Closed-loop AM-tACS