CIFASD 5 tDCS and Cognitive Training

NCT05456321 | Recruiting FDA Device

• 1 other identifier: PSYCH-2022-30910
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change in Oral Word Reading Fluency performance

  Visit 1 and Visit 5 (approx. 3 weeks apart)

• Change in Math Fluency performance

  Visit 1 and Visit 5 (approx. 3 weeks apart)

Study Arms (2)

Cognitive Training and Active tDCS

ACTIVE COMPARATOR

5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).

Device: Active tDCS; Behavioral: Cognitive Training

Cognitive Training and Sham tDCS

SHAM COMPARATOR

5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).

Behavioral: Cognitive Training; Device: Sham tDCS

Interventions

Active tDCS DEVICE

Active Transcranial Direct Current Stimulation (tDCS)

Cognitive Training and Active tDCS

Cognitive Training BEHAVIORAL

Computerized Cognitive Training

Cognitive Training and Active tDCS; Cognitive Training and Sham tDCS

Sham tDCS DEVICE

Sham Transcranial Direct Current Stimulation (tDCS)

Cognitive Training and Sham tDCS

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeffrey R Wozniak, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Wozniak, PhD

CONTACT

1-612-598-0041; jwozniak@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and families will be blinded. The principal investigator will be blinded. The research staff member coordinating the visit will be blinded. The care provider is not involved in the research and is, therefore, blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized allocation to active tDCS or placebo (sham tDCS).

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: July 13, 2022
• Study Start: November 10, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)