Cognitive training with brain stimulation for children with fetal alcohol exposure
Official title: tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
Run by University of Minnesota · NCT05456321 · Data updated 2026-11-12
This study is testing whether a combination of brain training and gentle brain stimulation can help children and teens who were exposed to alcohol before birth improve their thinking and learning skills.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 17 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | November 10, 2022 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT05456321 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 8 to 17 years with documented heavy prenatal alcohol exposure and a diagnosis of Fetal Alcohol Spectrum Disorders.
✕Probably not a fit
Patients with substance abuse issues, serious psychiatric disorders, or other neurological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the effects of cognitive training combined with transcranial direct current stimulation (tDCS) on children and adolescents aged 8 to 17 years who have been prenatally exposed to alcohol. It is a randomized, placebo-controlled study that includes a baseline cognitive assessment, followed by five sessions of tDCS, with participants receiving either active or sham stimulation. The study aims to address the neurocognitive impairments associated with Fetal Alcohol Spectrum Disorders (FASD) and evaluate improvements in learning, attention, and decision-making skills. A follow-up cognitive assessment will be conducted after the intervention to measure outcomes.
Why it matters
Potential benefit: If successful, this study could provide new therapeutic options to improve cognitive functioning in children affected by prenatal alcohol exposure.
How similar studies have gone: While there have been few treatment studies for FASD, this approach combining cognitive training with tDCS is relatively novel and has not been extensively tested in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). * An available parent or legal guardian capable of giving informed consent Exclusion Criteria: * Substance abuse in the participant * Neurological condition or other developmental disorder * Serious psychiatric disorder known to affect brain functioning and cognitive performance Birthweight \< 1500 grams * MRI contraindication * tDCS contraindication
Where it's running
-
University of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Jeffrey R Wozniak, Ph.D. — University of Minnesota
- Study coordinator: Jeffrey Wozniak, PhD
- Email: jwozniak@umn.edu
- Phone: 1-612-598-0041
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.