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Trial record 11 of 36 for:    fetal alcohol children

Cognitive Training and tDCS for Children With FASD

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ClinicalTrials.gov Identifier: NCT03361293
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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).

Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorders Device: Active tDCS Behavioral: Cognitive training Device: Sham tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomized allocation to active tDCS or placebo (sham tDCS).
Masking: Quadruple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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).
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

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).
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)




Primary Outcome Measures :
  1. BrainHQ learning rate [ Time Frame: Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days ]
    Learning rate during computerized cognitive training


Secondary Outcome Measures :
  1. Delis-Kaplan Executive Function System (D-KEFS) [ Time Frame: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline) ]
    D-KEFS cognitive battery measuring executive functioning skills

  2. 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) ]
    Parent-report rating of executive functioning skills

  3. NIH Toolbox [ Time Frame: NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline) ]
    NIH Toolbox measure of cognitive functioning



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361293


Contacts
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Contact: Jeffrey R Wozniak, Ph.D. 612-273-9741 jwozniak@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Jeffrey R Wozniak, Ph.D.    612-273-9741    jwozniak@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Jeffrey Wozniak, Ph.D. University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03361293     History of Changes
Other Study ID Numbers: 00001984
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders