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Neuromodulation and Mindfulness Patients With AUD

Key facts

Who runs it
Charite University, Berlin, Germany
Where
Germany1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
140 people, planned
Started
20 Mar 2024
Expected to end
30 Jun 2027
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Transcutaneous vagus nerve stimulation
  • Closed-loop AM-tACS
Record updated
20 March 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

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

Who cannot take part

  • intake of anticonvulsive or high-potency antipsychotic medication
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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).

The 4 groups in the trial

  • Active transcutaneous vagus nerve stimulationExisting treatment, for comparison

    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: Transcutaneous vagus nerve stimulation

  • Sham transcutaneous vagus nerve stimulationSham treatment, for comparison

    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: Transcutaneous vagus nerve stimulation

  • Closed-loop AM-tACS increase frontal midline theta oscillationExisting treatment, for comparison

    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: Closed-loop AM-tACS

  • Closed-loop AM-tACS decrease frontal midline theta oscillationSham treatment, for comparison

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

    Treatment: Closed-loop AM-tACS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD
Fit questions
Built from NCT06308484, who can take part
Record updated
20 March 2026