Non-invasive Brain Stimulation of the Prefrontal Cortex in Substance Use Disorders

NCT05471154 | Completed

• 1 other identifier: 22022NIBSSUD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

AUD; SUD; tDCS; NIBS; craving; abstinence; EEG

Outcome Measures

Primary Outcomes (1)

• Abstinence

  1 month after the last stimulation session, verbally self-reported abstinence status will be registered. To do so the Quick Drinking Screen (QDS) will be used during a phone call by the researcher.

  1 month after the intervention

Secondary Outcomes (10)

• ERP measures

  Total estimated period of one week: pre-intervention (on day 1;T1), after a first stimulation session (day 1, 30 minutes after T1) and after the full intervention of 5 sessions (on day 5,4 days after T1)

• Craving measures

  Total estimated period of one week: measure pre-intervention (day 1, T1) and after every stimulation session (T1 + 1 hour, T1 + 1 day, T1 + 2 days, T1 + 3 days and T1+ 4 days)

• Effortful control scale (EC)

  The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending)

• resting state EEG in alpha band

  otal estimated period of one week: pre-intervention (on day 1;T1), after a first stimulation session (day 1, 30 minutes after T1) and after the full intervention of 5 sessions (on day 5,4 days after T1)

• Behavioral inhibition system/behavioral approach system (BIS/BAS) Scale

  The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending)

Study Arms (2)

Active HD-tDCS

EXPERIMENTAL

Half of all subjects will receive active HD-tDCS (randomly assigned): anodal stimulation on the right dorsolateral prefrontal cortex. Stimulation will consist of 20 minutes 2mA anodal stimulation of the right dorsolateral prefrontal cortex.

Device: High Definition transcranial direct current stimulation (HD-tDCS)

Sham HD-tDCS

SHAM COMPARATOR

Half of all subjects will receive sham HD-tDCS (randomly assigned). A ramp-up of 1 minute will be used to induce the same feelings as during the active tDCS, but will then stop the stimulation. A short ramp up is repeated in the last minute of the protocol.

Device: High Definition transcranial direct current stimulation (HD-tDCS)

Interventions

High Definition transcranial direct current stimulation (HD-tDCS) DEVICE

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.

Active HD-tDCS; Sham HD-tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-V criteria for alohol use disorder
• dutch speaking
• years old
• abstinence in the past 10 days

You may not qualify if:

• diagnosis or family history of epilepsy
• a history of severe brain injury
• a cardiac pacemaker or electronic implants
• migraine
• a scalp skin condition
• pregnancy
• concurrent treatment with benzodiazepines
• hairstyle incompatible with EEG-measurements
• a psychotic disorder or neurological disease
• severe cognitive impairment defined as a score lower than 10 on the Montreal Cognitive Assessment (MoCA).

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Multiversum

Boechout, Antwerpen, 2530, Belgium

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Natacha Deroost, PhD

  Vrije Universiteit Brussel

  STUDY CHAIR

• Kris Baetens, PhD

  Vrije Universiteit Brussel

  STUDY DIRECTOR

• Geert Dom, MD

  PC Multiversum Boechout

  STUDY CHAIR

• Marianne Destoop, MD

  PC Multiversum Boechout

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind: another researcher than the one collecting data will program the codes of the ad verum vs. sham stimulation so that both participant and researcher (collecting data) are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, High-Definition transcranial direct current stimulation is used as treatment/intervention (HD-tDCS). HD-tDCS will be applied with a current of 2 mA during 20 minutes. Participants are semi-randomly assigned to the two experimental groups (active stimulation vs. sham) by the coordinating researcher, taking into account the sex of the participant. The sham condition will use the same montage but stop stimulation after a short ramp-up of 1 minute).

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 22, 2022
• Study Start: September 22, 2022
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: February 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)