Fetal Alcohol Spectrum Disorders
Conditions
Brief 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.
Interventions
DEVICEActive tDCS
Active Transcranial Direct Current Stimulation (tDCS)
BEHAVIORALCognitive Training
Computerized Cognitive Training
DEVICESham tDCS
Sham Transcranial Direct Current Stimulation (tDCS)
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants and families will be blinded. The principal investigator will be blinded. The research staff member coordinating the visit will be blinded. The care provider is not involved in the research and is, therefore, blinded.
Intervention model description
1:1 randomized allocation to active tDCS or placebo (sham tDCS).
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Continuous Performance Test performance | After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks) | Change in Continuous Performance Test performance |
| Change in Delis-Kaplan Executive Function System -Trail Making performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | Change in Delis-Kaplan Executive Function System - Trail Making performance |
| Change in Delis-Kaplan Executive Function System Color Word Interference performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | Change in Delis-Kaplan Executive Function System - Color Word Interference performance |
| Change in Wechsler Digit Span performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance |
| Change in Wechsler Picture Span performance | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Word Reading Fluency performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | Change in Oral Word Reading Fluency performance |
| Change in Math Fluency performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | Change in Mathematics Fluency performance |
Countries
United States
Contacts
CONTACTJeffrey Wozniak, PhD
PRINCIPAL_INVESTIGATORJeffrey R Wozniak, Ph.D.
University of Minnesota
Outcome results
None listed