Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
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).
Status | Recruiting |
Enrollment | 70 |
Est. completion date | May 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Continuous Performance Test performance | Change in Continuous Performance Test performance | After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks) | |
Primary | Change in Delis-Kaplan Executive Function System -Trail Making performance | Change in Delis-Kaplan Executive Function System - Trail Making performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | |
Primary | Change in Delis-Kaplan Executive Function System Color Word Interference performance | Change in Delis-Kaplan Executive Function System - Color Word Interference performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | |
Primary | Change in Wechsler Digit Span performance | Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | |
Primary | Change in Wechsler Picture Span performance | Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | |
Secondary | Change in Oral Word Reading Fluency performance | Change in Oral Word Reading Fluency performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | |
Secondary | Change in Math Fluency performance | Change in Mathematics Fluency performance | Visit 1 and Visit 5 (approx. 3 weeks apart) |
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