CIFASD 5 tDCS and Cognitive Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD

Conditions
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Fetal Alcohol Spectrum Disorders

Intervention / Treatment
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* Device: Active tDCS
* Behavioral: Cognitive Training
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomized allocation to active tDCS or placebo (sham tDCS).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Training and Active tDCS<br>5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions). | Device: Active tDCS<br>* Active Transcranial Direct Current Stimulation (tDCS)<br>Behavioral: Cognitive Training<br>* Computerized Cognitive Training<br>|
| Sham Comparator: Cognitive Training and Sham tDCS<br>5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions). | Behavioral: Cognitive Training<br>* Computerized Cognitive Training<br>Device: Sham tDCS<br>* Sham Transcranial Direct Current Stimulation (tDCS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oral Word Reading Fluency performance | Change in Oral Word Reading Fluency performance | Visit 1 and Visit 5 (approx. 3 weeks apart) | 
| Change in Math Fluency performance | Change in Mathematics Fluency performance | Visit 1 and Visit 5 (approx. 3 weeks apart) |