CIFASD 5 tDCS and Cognitive Training
Primary Purpose
Fetal Alcohol Spectrum Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Cognitive Training
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders
Eligibility 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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Cognitive Training and Active tDCS
Cognitive Training and Sham tDCS
Arm Description
5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).
5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).
Outcomes
Primary Outcome Measures
Change in Continuous Performance Test performance
Change in Continuous Performance Test performance
Change in Delis-Kaplan Executive Function System -Trail Making performance
Change in Delis-Kaplan Executive Function System - Trail Making performance
Change in Delis-Kaplan Executive Function System Color Word Interference performance
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Change in Wechsler Digit Span performance
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Change in Wechsler Picture Span performance
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
Secondary Outcome Measures
Change in Oral Word Reading Fluency performance
Change in Oral Word Reading Fluency performance
Change in Math Fluency performance
Change in Mathematics Fluency performance
Full Information
NCT ID
NCT05456321
First Posted
June 10, 2022
Last Updated
December 13, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05456321
Brief Title
CIFASD 5 tDCS and Cognitive Training
Official Title
tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 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 transcranial direct current stimulation (tDCS) in children and adolescents with PAE. The study involves a baseline visit with cognitive testing, 5 sessions of tDCS (including the baseline visit) with active and sham arms, a 6th visit for cognitive testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomized allocation to active tDCS or placebo (sham tDCS).
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training and Active tDCS
Arm Type
Active Comparator
Arm Description
5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).
Arm Title
Cognitive Training and Sham tDCS
Arm Type
Sham Comparator
Arm Description
5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
Active Transcranial Direct Current Stimulation (tDCS)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Computerized Cognitive Training
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Sham Transcranial Direct Current Stimulation (tDCS)
Primary Outcome Measure Information:
Title
Change in Continuous Performance Test performance
Description
Change in Continuous Performance Test performance
Time Frame
After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
Title
Change in Delis-Kaplan Executive Function System -Trail Making performance
Description
Change in Delis-Kaplan Executive Function System - Trail Making performance
Time Frame
Visit 1 and Visit 5 (approx. 3 weeks apart)
Title
Change in Delis-Kaplan Executive Function System Color Word Interference performance
Description
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Time Frame
Visit 1 and Visit 5 (approx. 3 weeks apart)
Title
Change in Wechsler Digit Span performance
Description
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Time Frame
Visit 1 and Visit 5 (approx. 3 weeks apart)
Title
Change in Wechsler Picture Span performance
Description
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
Time Frame
Visit 1 and Visit 5 (approx. 3 weeks apart)
Secondary Outcome Measure Information:
Title
Change in Oral Word Reading Fluency performance
Description
Change in Oral Word Reading Fluency performance
Time Frame
Visit 1 and Visit 5 (approx. 3 weeks apart)
Title
Change in Math Fluency performance
Description
Change in Mathematics Fluency performance
Time Frame
Visit 1 and Visit 5 (approx. 3 weeks apart)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Wozniak, PhD
Phone
1-612-598-0041
Email
jwozniak@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Wozniak, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Wozniak, Ph.D.
Email
jwozniak@umn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD with other researchers.
Learn more about this trial
CIFASD 5 tDCS and Cognitive Training
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