CIFASD 5 tDCS and Cognitive Training

University of Minnesota70 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Active tDCSDEVICE

Active Transcranial Direct Current Stimulation (tDCS)

Cognitive TrainingBEHAVIORAL

Computerized Cognitive Training

Sham tDCSDEVICE

Sham Transcranial Direct Current Stimulation (tDCS)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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

Change in Delis-Kaplan Executive Function System - Trail Making performance