N/A N=44 Randomized Quadruple-blind Treatment

Cognitive Training and tDCS for Children With FASD

Fetal Alcohol Spectrum Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03361293 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: BrainHQ Learning Rate — 867.6; 861.7 milliseconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active tDCS (Device); Cognitive training (Behavioral); Sham tDCS (Device)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY BrainHQ Learning Rate	867.6; 861.7	—
SECONDARY Change in D-KEFS Verbal Fluency - Letter	-0.11; -0.05	—
SECONDARY Change in D-KEFS Verbal Fluency - Category	-3.68; -3.42	—
SECONDARY Change in D-KEFS Trail-making - Numbers	1.11; 1.37	—
SECONDARY Change in D-KEFS Trail-making - Letters	1.05; -2.95	—
SECONDARY Change in D-KEFS Trail-making - Combined	-1.16; -2.05	—
SECONDARY Delis Rating of Executive Functioning (D-REF)	70.1; 73.2	—
SECONDARY Change in Flanker Inhibitory Control and Attention Task	2.05; 3.52	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03361293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.