CIFASD 5 tDCS and Cognitive Training

Not Applicable

Recruiting

• Conditions: Fetal Alcohol Spectrum Disorders
• Interventions: Behavioral: Cognitive Training; Device: Active tDCS; Device: Sham tDCS

• Registration Number: NCT05456321
• Lead Sponsor: University of Minnesota

Brief Summary

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).

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 transcranial direct current stimulation (tDCS) in children and adolescents with PAE. The study involves a baseline visit with cognitive testing, 5 sessions of tDCS (including the baseline visit) with active and sham arms, a 6th visit for cognitive testing.

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Study Start: 2022-11-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Training and Sham tDCS	Cognitive Training	5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).
Cognitive Training and Active tDCS	Cognitive Training	5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).
Cognitive Training and Sham tDCS	Sham tDCS	5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).
Cognitive Training and Active tDCS	Active tDCS	5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).

Primary Outcome Measures

Name	Time	Method
Change in Continuous Performance Test performance	After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)	Change in Continuous Performance Test performance
Change in Delis-Kaplan Executive Function System Color Word Interference performance	Visit 1 and Visit 5 (approx. 3 weeks apart)	Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Change in Wechsler Digit Span performance	Visit 1 and Visit 5 (approx. 3 weeks apart)	Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Change in Wechsler Picture Span performance	Visit 1 and Visit 5 (approx. 3 weeks apart)	Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
Change in Delis-Kaplan Executive Function System -Trail Making performance	Visit 1 and Visit 5 (approx. 3 weeks apart)	Change in Delis-Kaplan Executive Function System - Trail Making performance

Secondary Outcome Measures

Name	Time	Method
Change in Oral Word Reading Fluency performance	Visit 1 and Visit 5 (approx. 3 weeks apart)	Change in Oral Word Reading Fluency performance
Change in Math Fluency performance	Visit 1 and Visit 5 (approx. 3 weeks apart)	Change in Mathematics Fluency performance

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States