- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361293
Cognitive Training and tDCS for Children With FASD
February 19, 2021 updated by: University of Minnesota
Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)
BrainHQ Computerized cognitive training
|
Sham Comparator: 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).
|
BrainHQ Computerized cognitive training
Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BrainHQ Learning Rate
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in D-KEFS Verbal Fluency - Letter
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)
|
Delis Rating of Executive Functioning (D-REF)
Time Frame: 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.
|
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
|
Change in Flanker Inhibitory Control and Attention Task
Time Frame: 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.
|
NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey Wozniak, Ph.D., University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2017
Primary Completion (Actual)
January 30, 2020
Study Completion (Actual)
January 30, 2020
Study Registration Dates
First Submitted
November 20, 2017
First Submitted That Met QC Criteria
November 27, 2017
First Posted (Actual)
December 4, 2017
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
February 19, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCH-2017-26075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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