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NCT Number: NCT05456321

CIFASD 5 tDCS and Cognitive Training

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).

Recruiting

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location status: Recruiting

Location contact

Jeffrey R Wozniak, Ph.D.

CONTACT

[email protected]

About this study

Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with transcranial direct current stimulation (tDCS) in children and adolescents with PAE. The study involves a baseline visit with cognitive testing, 5 sessions of tDCS (including the baseline visit) with active and sham arms, a 6th visit for cognitive testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

Active Transcranial Direct Current Stimulation (tDCS)

Cognitive training

Behavioral

Computerized Cognitive Training

Sham tDCS

Device

Sham Transcranial Direct Current Stimulation (tDCS)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Change in Oral Word Reading Fluency performance

    Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)

    Change in Oral Word Reading Fluency performance

  2. Change in Math Fluency performance

    Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)

    Change in Mathematics Fluency performance

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Wozniak, PhD

CONTACT

[email protected]

1-612-598-0041

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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