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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training and Active tDCS | Active Comparator | 5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions). |
|
| Cognitive Training and Sham tDCS | Sham Comparator | 5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | Active Transcranial Direct Current Stimulation (tDCS) |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Wozniak, PhD | Contact | 1-612-598-0041 | jwozniak@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey R Wozniak, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55454 | United States |
There is no plan to share IPD with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2023 | Oct 26, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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1:1 randomized allocation to active tDCS or placebo (sham tDCS).
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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.
| Cognitive Training | Behavioral | Computerized Cognitive Training |
|
| Sham tDCS | Device | Sham Transcranial Direct Current Stimulation (tDCS) |
|
| Visit 1 and Visit 5 (approx. 3 weeks apart) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |