Clinical trial NCT03361293: Cognitive Training and tDCS for Children With FASD
Official title: Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
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 10 - 16 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 tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.

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: BrainHQ Learning Rate
timeFrame: Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.
Secondary outcomes:
measure: Change in D-KEFS Verbal Fluency - Letter
timeFrame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
measure: Change in D-KEFS Verbal Fluency - Category
timeFrame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
measure: Change in D-KEFS Trail-making - Numbers
timeFrame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
measure: Change in D-KEFS Trail-making - Letters
timeFrame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
measure: Change in D-KEFS Trail-making - Combined
timeFrame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
measure: Delis Rating of Executive Functioning (D-REF)
timeFrame: D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section
measure: Change in Flanker Inhibitory Control and Attention Task
timeFrame: NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeffrey Wozniak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boroda E, Krueger AM, Bansal P, Schumacher MJ, Roy AV, Boys CJ, Lim KO, Wozniak JR. A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder. Brain Stimul. 2020 Jul-Aug;13(4):1059-1068. doi: 10.1016/j.brs.2020.04.015. Epub 2020 Apr 28.