N/A Completed N=44 Randomized Quadruple-blind Treatment

Cognitive Training and tDCS for Children With FASD

Fetal Alcohol Spectrum Disorders

Source: ClinicalTrials.gov NCT03361293 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcomePrimary: BrainHQ Learning Rate — 867.6; 861.7 milliseconds

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).

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	—

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. Informational only — not medical advice.