Recruiting

tDCS & Cognitive Training

Sponsor:

University of Minnesota

Code:

NCT05456321

Conditions

Fetal Alcohol Spectrum Disorders

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Active tDCS

Cognitive Training

Sham tDCS

Study Details

Brief summary:

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).

Conditions

Fetal Alcohol Spectrum Disorders

Study ID

NCT05456321

Start date

Nov 10, 2022

Status verified date

Jan, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cognitive Training and Active tDCS

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

sham comparator: Cognitive Training and Sham tDCS

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

Interventions

Active tDCS

Active Transcranial Direct Current Stimulation (tDCS)

Cognitive Training

Computerized Cognitive Training

Sham tDCS

Sham Transcranial Direct Current Stimulation (tDCS)

Primary outcome measure

  • 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 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 Color Word Interference performance [ Time Frame: Visit 1 and Visit 5 (approx. 3 weeks apart) ]
  • Change in Wechsler Digit Span performance [ Time Frame: Visit 1 and Visit 5 (approx. 3 weeks apart) ]
  • Change in Wechsler Picture Span performance [ Time Frame: Visit 1 and Visit 5 (approx. 3 weeks apart) ]

Central Contacts and Locations

Central contacts

Jeffrey Wozniak, PhD

1-612-598-0041jwozniak@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Jeffrey R Wozniak, Ph.D.

jwozniak@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-20.