CIFASD 5 tDCS and Cognitive Training

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456321
• Other study ID #: PSYCH-2022-30910
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: Jeffrey Wozniak, PhD
• Phone: 1-612-598-0041
• Email: jwozniak[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Device:
• Active tDCS
Active Transcranial Direct Current Stimulation (tDCS)

Behavioral:
• Cognitive Training
Computerized Cognitive Training

Device:
• Sham tDCS
Sham Transcranial Direct Current Stimulation (tDCS)

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Continuous Performance Test performance	Change in Continuous Performance Test performance	After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
Primary	Change in Delis-Kaplan Executive Function System -Trail Making performance	Change in Delis-Kaplan Executive Function System - Trail Making performance	Visit 1 and Visit 5 (approx. 3 weeks apart)
Primary	Change in Delis-Kaplan Executive Function System Color Word Interference performance	Change in Delis-Kaplan Executive Function System - Color Word Interference performance	Visit 1 and Visit 5 (approx. 3 weeks apart)
Primary	Change in Wechsler Digit Span performance	Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance	Visit 1 and Visit 5 (approx. 3 weeks apart)
Primary	Change in Wechsler Picture Span performance	Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance	Visit 1 and Visit 5 (approx. 3 weeks apart)
Secondary	Change in Oral Word Reading Fluency performance	Change in Oral Word Reading Fluency performance	Visit 1 and Visit 5 (approx. 3 weeks apart)
Secondary	Change in Math Fluency performance	Change in Mathematics Fluency performance	Visit 1 and Visit 5 (approx. 3 weeks apart)