Clinical trial NCT05456321: CIFASD 5 tDCS and Cognitive Training
Official title: tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized allocation to active tDCS or placebo (sham tDCS).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Continuous Performance Test performance
timeFrame: After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
measure: Change in Delis-Kaplan Executive Function System -Trail Making performance
timeFrame: Visit 1 and Visit 5 (approx. 3 weeks apart)
measure: Change in Delis-Kaplan Executive Function System Color Word Interference performance
timeFrame: Visit 1 and Visit 5 (approx. 3 weeks apart)
measure: Change in Wechsler Digit Span performance
timeFrame: Visit 1 and Visit 5 (approx. 3 weeks apart)
measure: Change in Wechsler Picture Span performance
timeFrame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Secondary outcomes:
measure: Change in Oral Word Reading Fluency performance
timeFrame: Visit 1 and Visit 5 (approx. 3 weeks apart)
measure: Change in Math Fluency performance
timeFrame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeffrey R Wozniak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: