tDCS + Cognitive Training for Alcoholism

(tDCS/AUD Trial)

Overseen By Megan Kazynski, MPH BS

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial direct current stimulation (tDCS), a brain stimulation technique, can enhance the effectiveness of cognitive training for individuals with alcohol use disorder. The goal is to determine if this combination can improve thinking skills and reduce relapse rates. Individuals who have struggled with alcohol misuse and have abstained from alcohol for at least a week may be suitable candidates. Participants will receive either real or sham (fake) tDCS during their cognitive training sessions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment options for alcohol use disorder.

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 prior data suggests that this method is safe for cognitive training in alcohol use disorder?

Research shows that transcranial direct current stimulation (tDCS) combined with cognitive training is generally well-tolerated by participants. Studies have found that tDCS can enhance thinking skills in individuals with substance use disorders. Specifically, it boosts self-control, processing speed, and attention, though these improvements are typically small.

Regarding safety, tDCS applies a low electrical current to the scalp, which most people tolerate well. Common side effects are mild and may include tingling, slight itching, or a headache. These effects are usually temporary and not serious.

Overall, while researchers continue to study this treatment, previous studies suggest it is safe, with only minor and manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of transcranial direct current stimulation (tDCS) with cognitive training for treating alcoholism because it offers a novel approach compared to traditional options like medication and behavioral therapy. Unlike standard treatments that mainly focus on managing withdrawal symptoms or modifying behavior, tDCS targets the brain directly by delivering a mild electrical current to enhance cognitive training. This could potentially improve brain function and decision-making, which are often impaired in individuals with alcoholism. Moreover, tDCS is non-invasive and painless, making it an appealing option for those seeking new ways to support recovery.

What evidence suggests that tDCS with cognitive training is effective for alcohol use disorder?

Research has shown that using transcranial direct current stimulation (tDCS) with mental exercises might aid individuals with alcohol use disorder (AUD). In this trial, participants will receive either active tDCS or sham tDCS, both combined with cognitive training. One study found that applying tDCS to the front part of the brain reduced early relapse rates in patients who had completed detox. Another study indicated that AUD patients who received tDCS were more likely to remain sober after rehab. Additionally, tDCS has improved thinking skills in people with substance use disorders, including AUD. This suggests that tDCS could enhance the effectiveness of mental exercises for treating AUD. ^{4 5 6 7 8}

Who Is on the Research Team?

Kelvin O Lim, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21006331

A randomized placebo-controlled clinical trial Multiple sessions of prefrontal tDCS reduced the rate of early relapse in detoxified patients with alcohol-use disorder.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32360392/

A randomized controlled trial of transcranial direct-current ... These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.

3. mdpi.com mdpi.com/2076-3425/14/8/754

Is Transcranial Direct Current Stimulation Effective for ... Twenty-two studies met the criteria, suggesting tDCS can improve cognitive functions in SUD patients, though results varied. Effectiveness may depend on the ...

4. medrxiv.org medrxiv.org/content/10.1101/2021.06.24.21259446.full

Transcranial direct current stimulation combined with ... AUD patients who received tDCS applied to DLPFC showed a significantly higher abstinence rate during the weeks following rehabilitation.

5. nature.com nature.com/articles/s41386-023-01776-0

A systematic review and meta-analysis of neuromodulation ... Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (eg, craving, consumption, and relapse)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7332543/

A Meta-Analysis of Transcranial Direct Current Stimulation on ... tDCS can be an effective way to reduce craving of substance or food, and longer multiple stimulus durations in all can more effectively reduce craving.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25003110

A randomized, double-blind, sham-controlled trial In a doubleblind, sham-controlled trial, tDCS+CT improved inhibitory control, processing speed, and divided attention, although the effects were small. •.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04426214

Neuromodulation and Cognitive Training for Substance ... This study is testing a new intervention, namely tDCS-Augmented Cognitive Training, to engage these brain biomarkers to improve cognition and improve treatment ...