Cognitive Training and tDCS for Children With FASD

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361293
• Other study ID #: PSYCH-2017-26075
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2021
• Source: University of Minnesota
• Contact: n/a
• 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 10 - 16 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 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) administered with a Neuroelectrics StarStim Enobio cap system (active mode)

Behavioral:
• Cognitive training
BrainHQ Computerized cognitive training

Device:
• Sham tDCS
Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)

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	BrainHQ Learning Rate	Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance	Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.
Secondary	Change in D-KEFS Verbal Fluency - Letter	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Secondary	Change in D-KEFS Verbal Fluency - Category	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Secondary	Change in D-KEFS Trail-making - Numbers	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Secondary	Change in D-KEFS Trail-making - Letters	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Secondary	Change in D-KEFS Trail-making - Combined	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
Secondary	Delis Rating of Executive Functioning (D-REF)	The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.	D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section
Secondary	Change in Flanker Inhibitory Control and Attention Task	The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.	NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)