CIFASD 5 tDCS and Cognitive Training

tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD

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).

Study Overview

• Status: Recruiting
• Conditions: Fetal Alcohol Spectrum Disorders
• Intervention / Treatment: Device: Active tDCS; Behavioral: Cognitive Training; Device: Sham tDCS

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Wozniak, PhD; Phone Number: 1-612-598-0041; Email: jwozniak@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota
      • Contact: Jeffrey R Wozniak, Ph.D.; Email: jwozniak@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Training and Active tDCS; 5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).	Device: Active tDCS; Active Transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive Training; Computerized Cognitive Training
Sham Comparator: Cognitive Training and Sham tDCS; 5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).	Behavioral: Cognitive Training; Computerized Cognitive Training; Device: Sham tDCS; Sham Transcranial Direct Current Stimulation (tDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oral Word Reading Fluency performance	Change in Oral Word Reading Fluency performance	Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Math Fluency performance	Change in Mathematics Fluency performance	Visit 1 and Visit 5 (approx. 3 weeks apart)

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jeffrey R Wozniak, Ph.D., University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Alcohol Spectrum Disorders
• Other Study ID Numbers: PSYCH-2022-30910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No