NCT05456321 · University of Minnesota
CIFASD 5 tDCS and Cognitive Training
What this study is about
This is a randomly assigned compared against an inactive treatment trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (PAE).
View original scientific description
This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (PAE).
Interventions
DEVICE
Active tDCS
Active Transcranial Direct Current Stimulation (tDCS)
BEHAVIORAL
Cognitive Training
Computerized Cognitive Training
DEVICE
Sham tDCS
Sham Transcranial Direct Current Stimulation (tDCS)
Primary outcome measures
Change in Continuous Performance Test performance
Time frame: After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
Change in Continuous Performance Test performance
Change in Delis-Kaplan Executive Function System -Trail Making performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System - Trail Making performance
Change in Delis-Kaplan Executive Function System Color Word Interference performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Change in Wechsler Digit Span performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Change in Wechsler Picture Span performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations