tDCS + Cognitive Training for Fetal Alcohol Spectrum Disorders

Overseen By Jeffrey Wozniak, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Substance abuse, Neurological condition, others

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

Compensation: Varies

Number of Visits: 10

Duration: 3 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help children and teens with Fetal Alcohol Spectrum Disorders (FASD), a condition caused by prenatal alcohol exposure. Researchers aim to determine if combining cognitive training exercises with transcranial direct current stimulation (tDCS) can enhance brain function. Participants will receive either active tDCS (a non-invasive brain stimulation technique) or a sham version, alongside cognitive training. Ideal candidates are children and teens, ages 8 to 17, with confirmed prenatal alcohol exposure and a diagnosis related to FASD. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future treatments for FASD.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that transcranial direct current stimulation (tDCS) and cognitive training are safe for children and adolescents with prenatal alcohol exposure?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for children with fetal alcohol spectrum disorders (FASD). When combined with exercises to improve thinking skills, tDCS is usually safe and can be more effective than the exercises alone. Studies have not identified any major harmful side effects, indicating that this treatment is safe for children and teens exposed to alcohol before birth.

The thinking exercises alone are also safe and have been widely used to enhance learning and thinking skills. When paired with tDCS, study results are promising for both safety and effectiveness.

Overall, both treatments in this trial have demonstrated safety and good tolerance in similar groups of children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it combines two innovative approaches—transcranial Direct Current Stimulation (tDCS) and cognitive training—to potentially enhance brain function in individuals with Fetal Alcohol Spectrum Disorders (FASD). Unlike standard treatments that often focus on managing symptoms through behavioral therapy and medication, this trial explores the direct stimulation of the brain to improve executive functioning. By applying a mild electrical current to the brain while simultaneously engaging in cognitive exercises, this method aims to boost neural activity and cognitive skills more effectively. This combination could offer a more targeted and potentially faster improvement in cognitive abilities compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for Fetal Alcohol Spectrum Disorders?

Research has shown that transcranial direct current stimulation (tDCS) combined with brain exercises can enhance brain function in children with fetal alcohol spectrum disorders (FASD). In this trial, participants will receive either active tDCS with cognitive training or sham tDCS with cognitive training. Studies have found that tDCS, when paired with these exercises, offers more benefits than the exercises alone. This combination is safe for children. Additionally, brain exercises alone can improve thinking skills and everyday functioning in children. These findings suggest that using both tDCS and brain exercises together might effectively help children and teenagers exposed to alcohol before birth improve their cognitive skills. ^{1 2 3 5 6}

Who Is on the Research Team?

Jeffrey R Wozniak, Ph.D.

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for children and teens aged 8-17 with Fetal Alcohol Spectrum Disorders (FASD) due to heavy prenatal alcohol exposure. They need a parent or guardian to consent. It's not for those with substance abuse, other developmental disorders, serious psychiatric conditions affecting the brain, very low birthweight, or who can't have MRI or tDCS.

Inclusion Criteria

An available parent or legal guardian capable of giving informed consent

Documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated FASD diagnosis (FAS, partial FAS, or ARND)

Exclusion Criteria

My birthweight was under 1500 grams.

Substance abuse in the participant

Neurological condition or other developmental disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline visit with cognitive testing

1 day

1 visit (in-person)

Treatment

5 sessions of cognitive training with tDCS (active or sham)

3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive performance

2 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS
• Cognitive Training
• Sham tDCS

Trial Overview The study tests if cognitive training combined with an active brain stimulation technique called transcranial direct current stimulation (tDCS) helps improve brain function in kids with FASD. Some participants will receive a placebo version of tDCS instead of the active treatment.

How Is the Trial Designed?

Group I: Cognitive Training and Active tDCS Active Control 2 Interventions

5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).

Group II: Cognitive Training and Sham tDCS Placebo Group 2 Interventions

5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).

Active tDCS is already approved in United Kingdom, Brazil for the following indications:

Approved in United Kingdom as Transcranial Direct Current Stimulation for:

• Depression

Approved in Brazil as Transcranial Direct Current Stimulation for:

• Depression

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

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 assessed the safety of 1.5-mA transcranial direct current stimulation (tDCS) on 49 fasting healthy individuals during Ramadan, finding no serious adverse events or discomfort during the sessions.

There was no significant difference in side effects between active tDCS and sham stimulation, indicating that the tDCS protocol used is safe for fasting adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. Almousa, A., Alajaji, R., Alaboudi, M., et al.[2020]

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]

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]

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]

Transcranial direct current stimulation (tDCS) showed promising early efficacy in improving working memory performance in youth with cognitive persistent post-concussion symptoms, particularly on a dual task working memory test.

The study found that participants tolerated tDCS well, with the active tDCS group reporting fewer strong symptoms compared to the sham group, suggesting it could be a feasible adjunct to behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on cognitive performance in youth with persistent cognitive symptoms following concussion: a controlled pilot study. Quinn de Launay, K., Cheung, ST., Riggs, L., et al.[2022]

Transcranial direct current stimulation (tDCS) at 1mA for 10 minutes is well tolerated in children and adolescents aged 11-16, with a low rate of adverse events and no serious complications reported.

The study found no signs of harmful effects, such as epileptiform activity, in EEG recordings, suggesting that tDCS is a safe method for modulating brain activity in the developing brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. Moliadze, V., Andreas, S., Lyzhko, E., et al.[2015]

Transcranial direct current stimulation (tDCS) significantly enhanced working memory (WM) training performance in 62 participants, with effects lasting several months after training.

The study found that spacing tDCS sessions over a weekend break led to stronger improvements, and participants receiving right prefrontal stimulation showed benefits in nontrained visual and spatial WM tasks, indicating selective transfer of skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Working Memory Training with Transcranial Direct Current Stimulation. Au, J., Katz, B., Buschkuehl, M., et al.[2019]

In a study involving 50 boys with ADHD, multi-session anodal transcranial direct current stimulation (tDCS) over the right inferior frontal cortex combined with cognitive training did not show significant improvements in ADHD symptoms or cognitive performance compared to sham stimulation.

This research, being the largest randomized controlled trial of its kind, suggests that stimulating the right inferior frontal cortex may not be an effective neurotherapy for ADHD, highlighting the need for further investigation into alternative treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) combined with cognitive training in adolescent boys with ADHD: a double-blind, randomised, sham-controlled trial. Westwood, SJ., Criaud, M., Lam, SL., et al.[2023]

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]

Citations

1. 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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X20300942

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. sciencedirect.com sciencedirect.com/science/article/pii/S1090379825000479

Transcranial magnetic stimulation in children with fetal ... Our second hypothesis was that the use of high-frequency 10Hz-rTMS and iTBS in children with FASD leads to a significant improvement in attention, social- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05456321

NCT05456321 | CIFASD 5 tDCS and Cognitive Training This study will examine the effects of a cognitive remediation training augmented with transcranial direct current stimulation (tDCS) in children and ...

5. withpower.com withpower.com/trial/phase-fetal-alcohol-spectrum-disorders-6-2022-a3f79

tDCS + Cognitive Training for Fetal Alcohol Spectrum Disorders Research shows that combining transcranial direct current stimulation (tDCS) with cognitive training can improve brain function and outcomes in conditions with ...

6. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(20)30094-2/pdf

Brain Stimulation Journal Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and has permanent consequences for cogni- tion, learning, ...