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Recruiting NCT05456321

CIFASD 5 tDCS and Cognitive Training

No phase Interventional Fetal Alcohol Spectrum Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active tDCS, Cognitive Training, Sham tDCS.
Who it may be relevant to
Registry conditions: Fetal Alcohol Spectrum Disorders. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD

Overview

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.

Interventions

  • Device Active tDCS
    Active Transcranial Direct Current Stimulation (tDCS)
  • Behavioral Cognitive Training
    Computerized Cognitive Training
  • Device Sham tDCS
    Sham Transcranial Direct Current Stimulation (tDCS)

Primary outcome measures

  • 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)]
  • Change in Delis-Kaplan Executive Function System -Trail Making performance [Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)]
  • Change in Delis-Kaplan Executive Function System Color Word Interference performance [Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)]
  • Change in Wechsler Digit Span performance [Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)]
  • Change in Wechsler Picture Span performance [Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)]
Secondary outcome measures (2)
  • Change in Oral Word Reading Fluency performance [Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)]
  • Change in Math Fluency performance [Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT05456321 · PSYCH-2022-30910

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗