NCT03361293

Cognitive Training and tDCS for Children With FASD

Completed NA Results posted Last updated 17 March 2021

What this trial tests

NA trial testing Active tDCS in Fetal Alcohol Spectrum Disorders in 44 participants. Completed in 30 January 2020.

Timeline

20 November 2017

Primary endpoint
30 January 2020

30 January 2020

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	44
Start date	20 November 2017
Primary completion	30 January 2020
Estimated completion	30 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Active tDCS
• Cognitive training
• Sham tDCS

Conditions studied

• Fetal Alcohol Spectrum Disorders — all drugs for Fetal Alcohol Spectrum Disorders →

Sponsor

University of Minnesota

Who can join

Adults 10 to 16, any sex, with Fetal Alcohol Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

BrainHQ Learning Rate Primary · 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.

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

Group	Value	95% CI
Cognitive Training and Active tDCS	867.6	± 244.1
Cognitive Training and Sham tDCS	861.7	± 264.2

Change in D-KEFS Verbal Fluency - Letter Secondary · D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	-0.11	± 2.05
Cognitive Training and Sham tDCS	-0.05	± 1.68

Change in D-KEFS Verbal Fluency - Category Secondary · D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	-3.68	± 3.93
Cognitive Training and Sham tDCS	-3.42	± 3.37

Change in D-KEFS Trail-making - Numbers Secondary · D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	1.11	± 3.2
Cognitive Training and Sham tDCS	1.37	± 3.2

Change in D-KEFS Trail-making - Letters Secondary · D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	1.05	± 3.29
Cognitive Training and Sham tDCS	-2.95	± 3.73

Change in D-KEFS Trail-making - Combined Secondary · D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	-1.16	± 6.24
Cognitive Training and Sham tDCS	-2.05	± 6.18

Delis Rating of Executive Functioning (D-REF) Secondary · 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

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	70.1	± 11.9
Cognitive Training and Sham tDCS	73.2	± 9.5

Change in Flanker Inhibitory Control and Attention Task Secondary · NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)

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.

Group	Value	95% CI
Cognitive Training and Active tDCS	2.05	± 8.1
Cognitive Training and Sham tDCS	3.52	± 8.92

Adverse events — posted to ClinicalTrials.gov

Time frame: 56 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Training and Active tDCS

Serious: 0/19 (0%)

Deaths: 0/19

Cognitive Training and Sham tDCS

Serious: 0/19 (0%)

Deaths: 0/19

Other adverse events (17 terms — click to expand)

Reaction	System	Cognitive Training and Act…	Cognitive Training and Sha…
Sleepiness	General disorders	—	—
Itchiness	Skin and subcutaneous tissue disorders	—	—
Scalp discomfort	Skin and subcutaneous tissue disorders	—	—
Difficulty paying attention	General disorders	—	—
Tingling	Skin and subcutaneous tissue disorders	—	—
Headache	General disorders	—	—
Forgetfullness	General disorders	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—
Unusual feelings, attitudes, emotions	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Anxiety	General disorders	—	—
Balance problem	Ear and labyrinth disorders	—	—
Tooth pain	General disorders	—	—
Change in hearing	Ear and labyrinth disorders	—	—
Twitching / muscle movement	Musculoskeletal and connective tissue disorders	—	—
Dizziness	General disorders	—	—
Change in dominant hand function	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03361293 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.