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RECRUITING
NCT06308484
NA

Neuromodulation and Mindfulness Patients With AUD

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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).

Official title: Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-03-20

Completion Date

2027-06-30

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Charité - Berlin University of Medicine

Berlin, State of Berlin, Germany