NCT03361293

Cognitive Training and tDCS for Children With FASD

Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 - 16 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 tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.

Conditions

• Fetal Alcohol Spectrum Disorders

Interventions

Type	Name	Description
DEVICE	Active tDCS	Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)
BEHAVIORAL	Cognitive training	BrainHQ Computerized cognitive training
DEVICE	Sham tDCS	Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)

Timeline

• Start date: 2017-11-20
• Primary completion: 2020-01-30
• Completion: 2020-01-30
• First posted: 2017-12-04
• Last updated: 2021-03-17
• Results posted: 2021-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study