Non-invasive Brain Stimulation of the Prefrontal Cortex in Substance Use Disorders
NCT05471154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-02-11
Summary
Every year, alcohol causes 3 million deaths worldwide. Even though a lot of treatments already exist, many of them are characterized by a high percentage of drop-out or relapse. Transcranial direct current stimulation (tDCS), a NIBS, is receiving increased attention as a possible new addiction treatment. However, little consensus exists in the concrete parameters (e.g. montage, current, intensity). Moreover, a lot of tDCS research focuses on subjective outcomes, like the report of craving, which are more prone to different biases and fluctuations. In this study, we aim to investigate the effect of HD-tDCS, a more focal stimulation variant, on AUDs. Using this intervention, stimulation can be restricted to one hemisphere, controlling for possible inhibition effects of the cathode. A between-subject design will be carried out, including patients with an AUD. Participants will receive 5 sessions of either real or sham right anodal HD-tDCS over the dorsolateral prefrontal cortex (dlPFC). Craving will be accounted for at baseline and after every stimulation session. Moreover, we will measure the activity of the brain in rest and during two inhibition tasks (Go/NoGo and cue reactivity task). This objective measure will be carried out both before (baseline) and at two time points after the stimulation, to measure effects on both the short and longer term. One month after the intervention, abstinence will be checked through a follow-up phone call. Through this study, we aim to describe positive effects of right dlPFC stimulation on craving, abstinence, and EEG measures.
Conditions
- Alcohol Use Disorder (AUD)
Interventions
- DEVICE
-
High Definition transcranial direct current stimulation (HD-tDCS)
HD-tDCS is used at 2mA and during 20 minutes and with electrodes positioned on regions F4 (anode), Fp2, Fz, F8 and C4 (cathodes), according to the international 10-20 electroencephalogram system. 5 sessions are given on 5 following days. The material used in this study is the Soterix Medical 1x1 tES mini-CT and HD 4x1 splitter, produced by Soterix Medical Inc., 237 W 35th St, New York, NY 10001, United States of America.
Sponsors & Collaborators
-
Universitair Ziekenhuis Brussel
lead OTHER
Principal Investigators
-
Natacha Deroost, PhD · Vrije Universiteit Brussel
-
Kris Baetens, PhD · Vrije Universiteit Brussel
-
Geert Dom, MD · PC Multiversum Boechout
-
Marianne Destoop, MD · PC Multiversum Boechout
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-22
- Primary Completion
- 2024-09-20
- Completion
- 2024-09-20
Countries
- Belgium
Study Locations
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