tDCS + Cognitive Training for Alcoholism

(tDCS/AUD Trial)

Overseen By Megan Kazynski, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 3 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Unfortunately, about 2/3 of those entering treatment will relapse within one year. Cognitive impairments found in chronic alcohol use interfere with adaptive behavior needed for successful recovery. These cognitive impairments and their underlying neural substrates may provide promising new targets for interventions that can reduce relapse rates. Evidence suggests that cognitive training can improve cognition in individuals with AUD, strengthen neural networks mediating cognition, and improve treatment outcome. However, cognitive training is effort intensive, has small effect sizes, and may have limited durability. The primary objective of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to enhance cognition in alcohol use disorder and improve treatment outcome.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of all your medications (except for as-needed medications) for at least 30 days before starting. So, you won't need to stop your current medications, but they should be stable.

What data supports the effectiveness of the treatment tDCS + Cognitive Training for Alcoholism?

Research shows that transcranial direct current stimulation (tDCS) can reduce alcohol cravings and relapse rates in people with alcohol use disorder. Additionally, cognitive training has been found to help improve cognitive processes in those with alcohol dependence, suggesting that combining these treatments could be beneficial. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally well tolerated in humans, with studies showing no significant adverse events reported during trials for alcohol use disorder. It is considered a non-invasive brain stimulation technique that has been used safely in various clinical settings. ^{2 3 4 6 7}

How does the tDCS + Cognitive Training treatment for alcoholism differ from other treatments?

The tDCS + Cognitive Training treatment is unique because it combines brain stimulation (tDCS) with cognitive exercises to enhance brain plasticity and improve outcomes for alcohol dependence. This approach is different from traditional treatments as it directly targets brain function and cognitive processes, potentially reducing cravings and relapse rates. ^{2 3 4 8 9}

Research Team

Kelvin O Lim, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

This trial is for Veterans aged 22-65 with Alcohol Use Disorder who are receiving outpatient care and have been sober for at least a week. They must be able to consent, not in acute withdrawal, on stable medication doses, and without significant risks from participating or conditions that could affect the study's integrity.

Inclusion Criteria

You have abstained from consuming alcohol for a minimum of one week prior to the onset of study.

You are a veteran receiving outpatient clinical care services for Alcohol Use Disorder through the MVAHCS in the past six months.

You are currently diagnosed with Alcohol Use Disorder, as per the DSM-5 criteria.

Exclusion Criteria

A positive pregnancy test result in a woman of childbearing age/potential as agreed upon by the PI

Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)

You have trouble remembering things or difficulty understanding things as shown by a test score of 20 or lower on the Montreal Cognitive Assessment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of cognitive training concurrent with either sham or active tDCS

3 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for changes in binge drinking days, frontal-striatal functional connectivity, and cognitive test scores

2 months

3 visits (in-person)

Treatment Details

Interventions

• Active Transcranial Direct Current Stimulation (tDCS)
• Cognitive Training
• Sham Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if Active Transcranial Direct Current Stimulation (tDCS) paired with cognitive training can improve cognition in those with Alcohol Use Disorder better than a sham tDCS. It aims to see if this method strengthens brain networks and helps recovery.

Participant Groups

Group I: tDCS with Cognitive Training Experimental Treatment 1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes)

Group II: Sham tDCS with Cognitive Training Placebo Group 1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Findings from Research

In a study involving 509 alcohol-dependent patients, those who received Cognitive Bias Modification (CBM) training showed significantly lower relapse rates one year after treatment compared to those who only received standard treatment.

The effectiveness of CBM was linked to changes in alcohol-approach bias, with older patients and those with a strong initial approach bias benefiting the most from the intervention, suggesting that CBM can effectively address maladaptive cognitive processes in alcoholism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Eberl, C., Wiers, RW., Pawelczack, S., et al.[2022]

In a phase II clinical trial with 33 severe alcoholics, those receiving active transcranial direct current stimulation (tDCS) had a significantly lower relapse rate (50% abstinent) compared to the sham group (11.8% abstinent) after six months, indicating its potential efficacy in reducing relapse risk.

Participants in the tDCS group reported improved quality of life, particularly in the environment domain, suggesting that tDCS not only helps with abstinence but may also enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. Klauss, J., Penido Pinheiro, LC., Silva Merlo, BL., et al.[2016]

Transcranial direct current stimulation (tDCS) combined with cognitive bias modification (CBM) did not show a significant enhancement in treatment outcomes for alcohol-dependent patients, as there was no effect on abstinence duration after three months.

However, there was a trend suggesting that tDCS during CBM may reduce relapse rates after one year compared to sham stimulation, indicating potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. den Uyl, TE., Gladwin, TE., Rinck, M., et al.[2018]

In a clinical trial involving alcohol use disorder patients, 10 sessions of transcranial direct current stimulation (tDCS) significantly reduced alcohol craving scores compared to a sham treatment, with a large effect size of 1.1 for the real tDCS group.

The study found that 72.7% of patients receiving real tDCS remained abstinent from alcohol after 3 months, while 72.2% of the sham group relapsed, suggesting that tDCS may be an effective adjunctive treatment for reducing relapse in alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. Klauss, J., Anders, QS., Felippe, LV., et al.[2020]

Cognitive training has the potential to improve cognitive recovery in individuals with alcohol use disorders (AUDs), although it has been studied infrequently in this population.

While cognitive improvements are often observed with abstinence from alcohol, the effectiveness of training protocols in enhancing performance on tasks that are not directly trained is less consistent, indicating a need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training as a component of treatment of alcohol use disorder: A review. Nixon, SJ., Lewis, B.[2020]

This pilot study aims to evaluate the effectiveness of smartphone-based, multi-domain cognitive training with gamified elements for patients with alcohol use disorder (AUD), involving 60 participants in a randomized controlled trial.

The study will also assess the acceptability and feasibility of this mHealth intervention, gathering patient feedback to improve the tool, which could enhance conventional AUD treatments by addressing cognitive deficits that contribute to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain+ AlcoRecover: A Randomized Controlled Pilot-Study and Feasibility Study of Multiple-Domain Cognitive Training Using a Serious Gaming App for Treating Alcohol Use Disorders. Mistarz, N., Nielsen, AS., Andersen, K., et al.[2021]

Transcranial direct current stimulation (tDCS) shows potential as an adjunctive treatment for severe alcohol use disorder (SAUD), with some studies indicating it can reduce cravings and improve cognitive control.

However, the evidence is inconsistent, as not all studies found beneficial effects of tDCS, highlighting the need for further research and the development of evidence-based clinical guidelines for its use in treating SAUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Should Transcranial Direct Current Stimulation be Used in Populations With Severe Alcohol Use Disorder? A Clinically Oriented Systematic Review. Bollen, Z., Dormal, V., Maurage, P.[2022]

In a study involving 79 at-risk drinkers, the combination of cognitive bias modification (CBM) and transcranial direct current stimulation (tDCS) did not significantly reduce alcohol approach biases or alcohol consumption after treatment.

While there was a trend toward reduced drinking frequency over time, the intervention did not show significant effects on drinking quantity or heavy drinking days, suggesting limited effectiveness of this combined approach for treating alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Combined tDCS Over Right Inferior Frontal Cortex and Cognitive Bias Modification: Null Effects on Drinking and Alcohol Approach Bias. Claus, ED., Klimaj, SD., Chavez, R., et al.[2020]

The study involving 44 children with Fetal Alcohol Spectrum Disorders (FASD) found that transcranial direct current stimulation (tDCS) combined with cognitive training (CT) was feasible and well-tolerated, showing nominal improvements in attention compared to a sham treatment.

While tDCS-augmented CT did not significantly enhance working memory or other cognitive tasks, improvements in attention were correlated with reduced parent-reported attention deficits, suggesting potential benefits of this combined approach for children with FASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder. Boroda, E., Krueger, AM., Bansal, P., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? [2022]

2. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive training as a component of treatment of alcohol use disorder: A review. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Brain+ AlcoRecover: A Randomized Controlled Pilot-Study and Feasibility Study of Multiple-Domain Cognitive Training Using a Serious Gaming App for Treating Alcohol Use Disorders. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

How Should Transcranial Direct Current Stimulation be Used in Populations With Severe Alcohol Use Disorder? A Clinically Oriented Systematic Review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Combined tDCS Over Right Inferior Frontal Cortex and Cognitive Bias Modification: Null Effects on Drinking and Alcohol Approach Bias. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder. [2020]