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NCT05456321NARecruiting

CIFASD 5 tDCS and Cognitive Training

University of Minnesota

Start Date

11/10/2022

Completion Date

5/31/2027

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).

Detailed Description

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.

Eligibility Criteria

Age Range: 8 years to 17 years

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

Interventions

DEVICE

Active tDCS

BEHAVIORAL

Cognitive Training

DEVICE

Sham tDCS

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Conditions

Fetal Alcohol Spectrum Disorders

Locations

University of Minnesota

Minneapolis, Minnesota 55454

United States