Cognitive Training + Brain Stimulation for Alcoholism

Overseen By Clarista Berg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neurological sequelae, TBI, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help people with alcohol use disorder by using a gentle electrical brain stimulation combined with mental exercises. The goal is to improve their ability to stay sober for a long time. Researchers will also study how genetic differences affect treatment success.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a stable psychiatric disorder that is being treated, you can still participate.

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

Research shows that combining brain stimulation (tDCS) with cognitive training can improve brain function in people with alcohol-related brain issues. This combination has been effective in enhancing cognitive abilities in other conditions, suggesting it might help with alcoholism too. ^{1 2 3 4 5}

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

Research suggests that transcranial direct current stimulation (tDCS) is generally safe for humans, as it has been used in studies with healthy individuals and patients with neurocognitive disorders without major safety concerns. However, some studies have shown mixed results regarding its effectiveness, and it may not always improve cognitive functions as expected. ^{5 6 7 8 9}

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

This treatment combines cognitive training, which involves exercises to improve thinking skills, with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. Unlike traditional treatments, this approach targets brain function directly to enhance executive functions and reduce alcohol cravings, potentially leading to fewer relapses. ^{1 2 5 10 11}

Research Team

Jazmin Camchong, PhD

Principal Investigator

Univeristy of Minnesota Department of Psychiatry & Behavioral Sciences

Eligibility Criteria

This trial is for individuals with Alcohol Use Disorder (AUD) who are committed to staying in a treatment program and have been abstinent from alcohol. They must meet specific mental health criteria, not have other primary substance use disorders except caffeine or nicotine, and cannot have certain neurological conditions or contraindications for tDCS or MRI.

Inclusion Criteria

I plan to stay in the Lodging Plus program for the study's duration.

Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD

Abstinent from alcohol use

Exclusion Criteria

I have been diagnosed with Wernicke-Korsakoff syndrome.

Presence of a condition that would render study measures difficult or impossible to administer or interpret

Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 sessions of tDCS while in the Lodging Plus treatment program and 5 remote sessions after discharge, with cognitive training tasks and MRI sessions

2 weeks

5 in-person sessions, 5 remote sessions

Follow-up

Participants are monitored for relapse status and cognitive performance monthly for 4 months post-intervention

4 months

Monthly follow-up interviews

Treatment Details

Interventions

• Executive Function Focused Cognitive Training
• TaskFlow Transcranial Electrical Stimulation device

Trial Overview The TANGO study tests if combining brain stimulation (tDCS) targeting the DLPFC region with cognitive training can improve executive function and help maintain abstinence in AUD patients. It also explores how genetic profiles might influence treatment response.

Participant Groups

Group I: Participants receiving active transcranial direct current stimulation (tDCS) Experimental Treatment 2 Interventions

Participants in this group will receive 5 sessions of active transcranial direct current stimulation (tDCS) to dorsolateral prefrontal cortex (DLPFC) while in the Lodging Plus treatment program and then 5 remote sessions of active tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data.

Group II: Participants receiving active and sham active transcranial direct current stimulation (tDCS) Placebo Group 2 Interventions

Participants in this group will receive 5 sessions of sham-tDCS sessions while in the Lodging Plus treatment program and then 5 remote sessions of active-tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]

Cranial electrotherapy stimulation (CES) was found to significantly improve brain dysfunction in alcoholic patients, particularly on two subscales of the Revised Beta Examination that are linked to brain health.

CES may reduce the recovery time for reversible brain dysfunctions in alcoholics from months or years to just weeks, suggesting it could be a valuable treatment option for enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients. Smith, RB.[2019]

Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex significantly increased P3 amplitude in response to alcohol-related sounds in 49 alcoholic subjects, indicating enhanced frontal lobe activity, particularly in those classified as Lesch IV alcoholics.

Active tDCS also led to notable improvements in cognitive performance on the Frontal Assessment Battery (FAB) specifically for Lesch IV alcoholics, suggesting potential clinical benefits in addressing frontal dysfunction associated with alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory event-related potentials (P3) and cognitive changes induced by frontal direct current stimulation in alcoholics according to Lesch alcoholism typology. Nakamura-Palacios, EM., de Almeida Benevides, MC., da Penha Zago-Gomes, M., et al.[2022]

The study proposes a home-based rehabilitation protocol combining working memory training with non-invasive transcranial direct current stimulation (tDCS) to improve cognitive functions in patients with acquired brain injury, focusing on enhancing working memory and executive functioning.

Patients will be divided into two groups receiving either active tDCS or sham stimulation during a 2-week training period, with outcomes assessed to determine the effectiveness of tDCS in enhancing training gains and its potential impact on everyday activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRAINSTORMING: A study protocol for a randomised double-blind clinical trial to assess the impact of concurrent brain stimulation (tDCS) and working memory training on cognitive performance in Acquired Brain Injury (ABI). Assecondi, S., Hu, R., Eskes, G., et al.[2021]

In a clinical trial involving 106 smokers, transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex did not lead to significant improvements in smoking cessation, with no differences in days of abstinence across different stimulation doses (1 mA and 2 mA) compared to sham treatment.

The side effects of tDCS were mild, and participants could not distinguish between active and sham treatments, indicating that while tDCS is safe, it is not effective for helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of effect of transcranial direct current stimulation (tDCS) on short-term smoking cessation: Results of a randomized, sham-controlled clinical trial. Falcone, M., Bernardo, L., Wileyto, EP., et al.[2020]

The study involving 24 healthy young volunteers found that the foc.us transcranial direct current stimulation (tDCS) headset did not improve cognitive performance, specifically in working memory tasks, and actually decreased accuracy compared to sham stimulation.

These findings highlight the need for scientific validation of claims made by brain training products, as the advertised benefits of the foc.us headset were not supported by the experimental results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Unfocus" on foc.us: commercial tDCS headset impairs working memory. Steenbergen, L., Sellaro, R., Hommel, B., et al.[2022]

In a study involving 39 healthy young adults, repeated sessions of anodal high-definition transcranial direct current stimulation (HD-tDCS) over 4 weeks significantly improved executive control and psychomotor efficiency, with benefits increasing over time.

Unlike the sham group, which showed a return to baseline performance after 9 sessions, the anodal group maintained their improvements in attention, suggesting that repeated HD-tDCS has a cumulative positive effect on cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Repeated Anodal HD-tDCS on Attention in Healthy Young Adults. Lu, H., Liu, Q., Guo, Z., et al.[2020]

Transcranial direct current stimulation (tDCS) was found to be safe and well-tolerated in a study involving 20 patients with mild or major neurocognitive disorders, with an attrition rate of 0% and no serious adverse events reported.

However, the study did not find any statistically significant improvements in cognitive functioning when comparing the active tDCS group to the sham group, indicating that tDCS may not enhance cognitive performance in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. Inagawa, T., Yokoi, Y., Narita, Z., et al.[2022]

A meta-analysis of 27 studies found that single-session transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC) did not significantly improve overall executive function in healthy individuals, although some specific effects were noted.

Anodal unilateral tDCS showed a significant positive effect on updating tasks, particularly when using smaller anodes and extracranial cathodes, suggesting that the configuration of the stimulation can influence its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prefrontal tDCS on executive function: Methodological considerations revealed by meta-analysis. Imburgio, MJ., Orr, JM.[2019]

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 80 early-abstinent methamphetamine users, the combination of transcranial direct current stimulation (tDCS) and mindfulness-based substance abuse treatment (MBSAT) significantly improved executive functions and reduced cravings compared to a sham group.

The improvements in executive functions and reductions in cravings were correlated, suggesting that the combination of tDCS and MBSAT may work together to enhance cognitive and emotional processes in individuals recovering from substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Executive Functions and Reduced Craving in Youths with Methamphetamine Addiction: Evidence from Combined Transcranial Direct Current Stimulation with Mindfulness Treatment. Alizadehgoradel, J., Imani, S., Nejati, V., et al.[2022]

References

1. 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]

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

Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Auditory event-related potentials (P3) and cognitive changes induced by frontal direct current stimulation in alcoholics according to Lesch alcoholism typology. [2022]

4. England pubmed.ncbi.nlm.nih.gov

BRAINSTORMING: A study protocol for a randomised double-blind clinical trial to assess the impact of concurrent brain stimulation (tDCS) and working memory training on cognitive performance in Acquired Brain Injury (ABI). [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Lack of effect of transcranial direct current stimulation (tDCS) on short-term smoking cessation: Results of a randomized, sham-controlled clinical trial. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

"Unfocus" on foc.us: commercial tDCS headset impairs working memory. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Modulation of Repeated Anodal HD-tDCS on Attention in Healthy Young Adults. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effects of prefrontal tDCS on executive function: Methodological considerations revealed by meta-analysis. [2019]

10. 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]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Improved Executive Functions and Reduced Craving in Youths with Methamphetamine Addiction: Evidence from Combined Transcranial Direct Current Stimulation with Mindfulness Treatment. [2022]