University of Minnesota
Minneapolis, Minnesota, 55454, United States
Location status: Recruiting
NCT Number: NCT05456321
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).
Interested in participating?
Request Info8 year–17 year
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55454, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active Transcranial Direct Current Stimulation (tDCS)
Computerized Cognitive Training
Sham Transcranial Direct Current Stimulation (tDCS)
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
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
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 Intelligence Scale for Children or Wechsler Adult Intelligence 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 Scale Picture Span performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Oral Word Reading Fluency performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Mathematics Fluency performance
Contact information is provided by the study sponsor or research team.
University of Minnesota
Other
tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
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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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