Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT03361293
Brief Summary:
This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 - 16 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 tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.
Study:
NCT03361293
Study Brief:
Protocol Section:
NCT03361293