Cognitive training with brain stimulation for children with fetal alcohol exposure
tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05456321 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with substance abuse issues, serious psychiatric disorders, or other neurological conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.