Cognitive Training and tDCS for Children With FASD
Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)
1 other identifier
interventional
44
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedResults Posted
Study results publicly available
February 16, 2021
CompletedMarch 17, 2021
February 1, 2021
2.2 years
November 20, 2017
January 5, 2021
February 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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)
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)
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)
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)
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)
- +2 more secondary outcomes
Study Arms (2)
Cognitive Training and Active tDCS
ACTIVE COMPARATOR5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).
Cognitive Training and Sham tDCS
SHAM COMPARATOR5 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).
Interventions
Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)
BrainHQ Computerized cognitive training
Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
Boroda E, Krueger AM, Bansal P, Schumacher MJ, Roy AV, Boys CJ, Lim KO, Wozniak JR. A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder. Brain Stimul. 2020 Jul-Aug;13(4):1059-1068. doi: 10.1016/j.brs.2020.04.015. Epub 2020 Apr 28.
PMID: 32360392DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Wozniak, PhD, LP
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Wozniak, Ph.D.
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2017
First Posted
December 4, 2017
Study Start
November 20, 2017
Primary Completion
January 30, 2020
Study Completion
January 30, 2020
Last Updated
March 17, 2021
Results First Posted
February 16, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share