CIFASD 5 tDCS and Cognitive Training
ConditionFetal Alcohol Spectrum Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorUniversity of Minnesota
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active tDCS
DeviceActive Transcranial Direct Current Stimulation (tDCS)
Cognitive Training
BehavioralComputerized Cognitive Training
Sham tDCS
DeviceSham Transcranial Direct Current Stimulation (tDCS)
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Cognitive Training and Active tDCSActive comparator 2 interventions
Group B: Cognitive Training and Sham tDCSSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Continuous Performance Test performance
Change in Continuous Performance Test performance
Time frame
After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)2
Change in Delis-Kaplan Executive Function System -Trail Making performance
Change in Delis-Kaplan Executive Function System - Trail Making performance
Time frame
Visit 1 and Visit 5 (approx. 3 weeks apart)3
Change in Delis-Kaplan Executive Function System Color Word Interference performance
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Time frame
Visit 1 and Visit 5 (approx. 3 weeks apart)4
Change in Wechsler Digit Span performance
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Time frame
Visit 1 and Visit 5 (approx. 3 weeks apart)Secondary outcomes
1
Change in Oral Word Reading Fluency performance
Change in Oral Word Reading Fluency performance
Time frame
Visit 1 and Visit 5 (approx. 3 weeks apart)2
Change in Math Fluency performance
Change in Mathematics Fluency performance
Time frame
Visit 1 and Visit 5 (approx. 3 weeks apart)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov