Cognitive Training and tDCS for Children With FASD

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03361293

Enrollment

Registered

2017-12-04

Start date

2017-11-20

Completion date

2020-01-30

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Spectrum Disorders

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.

Interventions

DEVICEActive tDCS

Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)

BEHAVIORALCognitive training

BrainHQ Computerized cognitive training

DEVICESham tDCS

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

10 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
BrainHQ Learning Rate	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

Secondary

Measure	Time frame	Description
Change in D-KEFS Verbal Fluency - Category	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.
Change in D-KEFS Trail-making - Numbers	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.
Change in D-KEFS Trail-making - Letters	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.
Change in D-KEFS Verbal Fluency - Letter	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.
Delis Rating of Executive Functioning (D-REF)	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.
Change in Flanker Inhibitory Control and Attention Task	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.
Change in D-KEFS Trail-making - Combined	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cognitive Training and Active tDCS 5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	19
Cognitive Training and Sham tDCS 5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of placebo stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)	19
Total	38

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	2
Overall Study	Withdrawal by Subject	1	3

Baseline characteristics

Characteristic	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS	Total
Age, Categorical <=18 years	19 Participants	19 Participants	38 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Delis Rating of Executive Functioning (D-REF)	69.9 t-score STANDARD_DEVIATION 9	76.3 t-score STANDARD_DEVIATION 11.7	72.4 t-score STANDARD_DEVIATION 10.8
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) More than one race	6 Participants	2 Participants	8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	9 Participants	11 Participants	20 Participants
Region of Enrollment United States	19 participants	19 participants	38 participants
Sex: Female, Male Female	7 Participants	9 Participants	16 Participants
Sex: Female, Male Male	12 Participants	10 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 19
other Total, other adverse events	19 / 19	19 / 19
serious Total, serious adverse events	0 / 19	0 / 19

Outcome results

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

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Cognitive Training and Active tDCS	BrainHQ Learning Rate	867.6 milliseconds	Standard Deviation 244.1
Cognitive Training and Sham tDCS	BrainHQ Learning Rate	861.7 milliseconds	Standard Deviation 264.2

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.