tDCS + Cognitive Training for Alcoholism
(tDCS/AUD Trial)
Recruiting in Palo Alto (17 mi)
Overseen byKelvin O Lim, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Cognitive impairment, Psychosis, Mania, others
No Placebo Group
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.
12345Is 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.
23467How 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.
23489Eligibility 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.
+3 more
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.
+4 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: tDCS with Cognitive TrainingExperimental Treatment1 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 TrainingPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, MN
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
University of MinnesotaCollaborator
Minneapolis Veterans Affairs Medical CenterCollaborator
References
Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? [2022]Alcoholism is a progressive neurocognitive developmental disorder. Recent evidence shows that computerized training interventions (Cognitive Bias Modification, CBM) can reverse some of these maladaptively changed neurocognitive processes. A first clinical study of a CBM, called alcohol-avoidance training, found that trained alcoholic patients showed less relapse at one-year follow-up than control patients. The present study tested the replication of this result, and questions about mediation and moderation.
A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. [2016]Preliminary small studies have shown that transcranial direct current stimulation (tDCS) reduces craving in alcoholic subjects. It is unclear whether tDCS also leads to changes in clinically meaningful outcomes for alcohol dependence in a properly powered phase II randomized clinical trial. We aimed to investigate whether repetitive tDCS changes the risk of alcohol use relapse in severe alcoholics from outpatient services. Thirty-five subjects were randomized to receive active bilateral [left cathodal/right anodal over the dorsolateral prefrontal cortex (dlPFC)] repetitive (five consecutive days) tDCS (2 mA, 35 cm2, two times daily stimulation for 13 min with a 20-min interval) or sham-tDCS. There were two dropouts before treatment. From 33 alcoholic subjects, 17 (mean age 45.5±8.9 s.d., 16 males) were randomized to sham and 16 (44±7.8 s.d., 16 males) to real tDCS treatment. By the end of the six months of follow-up, two subjects treated with sham (11.8%) and eight treated with real tDCS (50%) were still alcohol-abstinent [p=0.02, Long-rank (Mantel-Cox) Test, HR=0.35 (95% CI, 0.14-0.85)]. No differences with regard to changes on scores of craving, frontal function, global mental status, depressive or anxiety symptoms were observed between groups. However, subjects from the tDCS group improved with regard to their overall perception of quality of life (p=0.02), and increased their scores in the environment domain (p=0.04) after treatment. Bilateral tDCS over dlPFC reduces relapse probability in severe alcoholic subjects and results in improved perception of quality of life.
A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining. [2018]Two studies showed an improvement in clinical outcomes after alcohol approach bias retraining, a form of Cognitive Bias Modification (CBM). We investigated whether transcranial direct current stimulation (tDCS) could enhance effects of CBM. TDCS is a neuromodulation technique that can increase neuroplasticity and has previously been found to reduce craving. One hundred alcohol-dependent inpatients (91 used for analysis) were randomized into three experimental groups in a double-blind parallel design. The experimental group received four sessions of CBM while receiving 2 mA of anodal tDCS over the dorsolateral prefrontal cortex (DLPFC). There were two control groups: One received sham stimulation during training and one received active stimulation at a different moment. Treatment outcomes were abstinence duration (primary) and relapse after 3 and 12 months, craving and approach bias (secondary). Craving and approach bias scores decreased over time; there were no significant interactions with experimental condition. There was no effect on abstinence duration after three months (χ2(2) = 3.53, p = 0.77). However, a logistic regression on relapse rates after one year (standard outcome in the clinic, but not-preregistered) showed a trend when relevant predictors were included; relapse was lower in the condition receiving active stimulation during CBM only when comparing to sham stimulation (B = 1.52, S.E. = .836, p = .07, without predictors: p = .19). No strong evidence for a specific enhancement effect of tDCS on CBM was found. However, in a post-hoc analysis, tDCS combined with CBM showed a promising trend on treatment outcome. Important limitations are discussed, and replication is necessary to find more reliable effects.
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]Background: Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, has been studied as an adjunctive therapeutic agent for alcohol dependence. In a previous study, we showed that five consecutive sessions of tDCS applied bilaterally over the dorsolateral prefrontal cortex (dlPFC) reduced relapse to the use of alcohol in alcohol use disorder (AUD) outpatients. However, no changes on craving scores were observed. In the present study, we investigated if an extended number of sessions of the same intervention would reduce craving and relapses for alcohol use in AUD inpatients. Methods: Thus, a randomized, double-blind, sham-controlled, clinical trial with parallel arms was conducted (https://clinicaltrials.gov/ct2/show/NCT02091284). AUD patients from two private and one public clinics for treatment of drug dependence were randomly allocated to two groups: real tDCS (5 × 7 cm2, 2 mA, for 20 min, cathodal over the left dlPFC, and anodal over the right dlPFC) and sham-tDCS. Real or sham-tDCS was applied once a day, every other day, in a total of 10 sessions. Craving was monitored by a 5-item obsessive compulsive drinking scale once a week (one time before, three times during and once after brain stimulation) over about 5 weeks. Results: Craving scores progressively decreased over five measurements in both groups but were significantly reduced only in the real tDCS group after treatment. Corrected Hedges' within-group (initial and final) effect sizes of craving scores were of 0.3 for the sham-tDCS and of 1.1 for the real tDCS group. Effect size was 3-fold larger in the real tDCS group. In addition, the between-group analysis on craving score difference was nearly significant, and the effect size was 0.58, in favor for a larger effect in the real tDCS group when compared to sham-tDCS. Furthermore, in a 3-months follow-up after intervention, 72.2% of sham-tDCS group relapsed to the alcohol use whereas 72.7% of tDCS group were abstinent. Conclusions: Multiple sessions of bilateral prefrontal tDCS were well tolerated with no significant adverse events. Thus, extended repetitive bilateral tDCS over the dlPFC is a promising adjunctive clinical tool that could be used to reduce alcohol craving and relapses and facilitate alcoholism cessation.
Cognitive training as a component of treatment of alcohol use disorder: A review. [2020]Cognitive training is an effective means of improving performance in a range of populations. Whether it may serve to facilitate cognitive recovery and longer-term outcomes in persons with alcohol use disorders (AUDs) is unclear. Here, we review historical and current literature and offer perspectives for model development and potential implementation.
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]Background: Patients with alcohol use disorder (AUD) exhibit deficits in various cognitive domains, including executive functioning, working memory, and learning and memory, which impede the effectiveness of conventional AUD treatment and enhance relapse. Mobile health (mHealth) services are promising in terms of delivering cognitive training in gamified versions. So far, studies examining the effects of mHealth-based cognitive training in AUD patients have, however, focused on specific rather than multiple cognitive domains and overlooked the importance of clinical outcomes. Furthermore, research has yet to investigate the acceptability and feasibility of this type of cognitive training. Aims: The aims of this pilot study are to examine (1) whether using smartphone-based, multi-domain cognitive training with gamified elements as part of conventional treatment for AUD indicate effect, and (2) whether the intervention is acceptable and feasible as a part of conventional treatment for AUD. Methods: Patients from the alcohol outpatient clinic, Odense Municipality, Denmark will be invited to participate in the study on a consecutive basis until a total of 60 patients have been recruited. The study will be performed as a combined parallel randomized controlled trial (RCT) and qualitative feasibility study. The patients will be randomly assigned to one of two groups. The intervention group (n = 30) will receive smartphone-based, multi-domain cognitive training with gamified elements together with treatment as usual (TAU). The active control group (n = 30) will receive a sham version of the same cognitive training together with TAU. Cognitive outcomes will be assessed via the training application at baseline and post-treatment. Clinical outcomes will be assessed at baseline, post-treatment, and at 6-month follow-up using the Addiction Severity Index. Furthermore, the 30 patients randomized to the intervention group will be invited to participate in the second phase, that is the feasibility study, at post-treatment. A questionnaire inquiring about the use of mHealth treatment in general will be administered. Further, feedback regarding functionality and meaningfulness of the application in addition to other qualitative aspects relating to the use of the application will be collected. The patients will also be asked to provide suggestions about how to improve and potentially implement the tool. Implications: It is anticipated that this pilot study will provide tentative evidence for the effectiveness of smartphone-based, multi-domain cognitive training as well as information about the usability and feasibility of this type of training, including acceptability and compliance. The study will also contribute with feedback derived from the patients about how to improve and implement the tool. If promising, the findings will be used to plan a large-scale RCT. Since cognitive deficits are not addressed in current treatments for AUD, gamified cognitive training delivered through smartphones may increase the effectiveness of current treatment for AUD as well as introduce more mHealth-based treatment that is both accessible and cost-effective.
How Should Transcranial Direct Current Stimulation be Used in Populations With Severe Alcohol Use Disorder? A Clinically Oriented Systematic Review. [2022]Background and rationale. Severe alcohol use disorder (SAUD) is a major public health concern, given its massive individual, interpersonal, and societal consequences. The available prevention and treatment programs have proven limited effectiveness, as relapse rates are still high in this clinical population. Developing effective interventions reducing the appearance and persistence of SAUD thus constitutes an experimental and clinical priority. Among the new therapeutic approaches, there is a growing interest for noninvasive neuromodulation techniques, and particularly for transcranial direct current stimulation (tDCS) as an adjunctive treatment in neuropsychiatric disorders, including SAUD. Methods. We propose a systematic review, based on preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, evaluating the available evidence on the effectiveness of tDCS to improve clinical interventions in SAUD. Results. We provide an integrative overview of studies applying tDCS in clinical populations with SAUD, together with a standardized methodological quality assessment. We show that the currently available data remain inconsistent. Some data suggested that tDCS can (1) reduce craving, relapse or alcohol-cue reactivity and (2) improve cognitive control and inhibition. However, other studies did not observe any beneficial effect of tDCS in SAUD. Conclusions. Capitalizing on the identified strengths and shortcomings of available results, we present evidence-based clinical guidelines to integrate tDCS in current clinical settings and to combine it with neurocognitive training.
A Randomized Trial of Combined tDCS Over Right Inferior Frontal Cortex and Cognitive Bias Modification: Null Effects on Drinking and Alcohol Approach Bias. [2020]Deriving novel treatments for alcohol use disorders (AUDs) is of critical importance, as existing treatments are only modestly effective for reducing drinking. Two promising strategies for treating AUDs include cognitive bias modification (CBM) and transcranial direct current stimulation (tDCS). While each strategy has shown positive results in reducing drinking or alcohol-related constructs (e.g., craving), initial tests of the combination of CBM and tDCS have shown mixed results. The present study investigated the degree to which combining CBM and tDCS (2.0 mA anodal current over F10) could reduce alcohol approach biases and alcohol consumption.
A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder. [2020]This study was a randomized double-blind sham-controlled trial examining the effects of transcranial direct current stimulation (tDCS) augmented cognitive training (CT) in children with Fetal Alcohol Spectrum Disorders (FASD). Prenatal alcohol exposure has profound detrimental effects on brain development and individuals with FASD commonly present with deficits in executive functions including attention and working memory. The most commonly studied treatment for executive deficits is CT, which involves repeated drilling of exercises targeting the impaired functions. As currently implemented, CT requires many hours and the observed effect sizes are moderate. Neuromodulation via tDCS can enhance brain plasticity and prior studies demonstrate that combining tDCS with CT improves efficacy and functional outcomes. TDCS-augmented CT has not yet been tested in FASD, a condition in which there are known abnormalities in neuroplasticity and few interventions.