CIFASD 5 tDCS and Cognitive Training for Fetal Alcohol Spectrum Disorders

This study is testing if combining active transcranial direct current stimulation (tDCS) with computerized cognitive training can help children and adolescents (ages 8-17) who have Fetal Alcohol Spectrum Disorders (FASD) due to prenatal alcohol exposure. Participants will receive either active tDCS or a sham (inactive) tDCS, along with cognitive training. Researchers will measure changes in attention and executive function (skills like planning and problem-solving) to see if the treatments are successful. The study is currently recruiting about 70 participants.

Study design
This is a randomized placebo-controlled study involving about 70 participants. It compares active tDCS with cognitive training to sham tDCS with cognitive training.
What's involved
You would have a baseline visit with cognitive testing, followed by 5 sessions of tDCS and cognitive training over approximately 5 weeks. There will be a final visit for cognitive testing.
Compensation
Not stated in the trial record.
Follow-up
Your performance on certain tests will be measured after each study visit (about every two weeks) for the duration of the study (10 visits, approximately 5 weeks).

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NCT05456321

CIFASD 5 tDCS and Cognitive Training

Recruiting
NAAges 8–17InterventionalTreatment
University of Minnesota
~70 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:Active tDCSCognitive TrainingSham tDCS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Continuous Performance Test performance
Measured over After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
+4 more outcomes measured
Fetal Alcohol Spectrum Disorders
1 sites across 1 states
Minnesota1
  • Jeffrey R Wozniak, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

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

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
  • Change in Continuous Performance Test performanceAfter 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 performanceVisit 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 performanceVisit 1 and Visit 5 (approx. 3 weeks apart)

    Change in Delis-Kaplan Executive Function System - Color Word Interference performance

  • Change in Wechsler Digit Span performanceVisit 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 performanceVisit 1 and Visit 5 (approx. 3 weeks apart)

    Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance