Cognitive Training and tDCS for Children With FASD

University of Minnesota (UMN)

Status: Completed

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Behavioral: Cognitive training; Device: Sham tDCS; Device: Active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03361293

PSYCH-2017-26075

Details and patient eligibility

About

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).

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Cognitive Training and Active tDCS

Active Comparator group

Description:

5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).

Treatment:

Behavioral: Cognitive training

Device: Active tDCS

Cognitive Training and Sham tDCS

Sham Comparator group

Description:

5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).

Treatment:

Behavioral: Cognitive training

Device: Sham tDCS