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CIFASD 5 tDCS and Cognitive Training

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05456321
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
56.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Active tDCS
  • Behavioral: Cognitive Training
  • Device: Sham tDCS
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 randomized allocation to active tDCS or placebo (sham tDCS).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:
tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 31, 2027
Anticipated Study Completion Date :
May 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cognitive Training and Active tDCS

5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).

Device: Active tDCS
Active Transcranial Direct Current Stimulation (tDCS)

Behavioral: Cognitive Training
Computerized Cognitive Training
Sham Comparator: Cognitive Training and Sham tDCS

5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).

Behavioral: Cognitive Training
Computerized Cognitive Training

Device: Sham tDCS
Sham Transcranial Direct Current Stimulation (tDCS)

Outcome Measures

Primary Outcome Measures

  1. Change in Continuous Performance Test performance [After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)]

    Change in Continuous Performance Test performance

  2. Change in Delis-Kaplan Executive Function System -Trail Making performance [Visit 1 and Visit 5 (approx. 3 weeks apart)]

    Change in Delis-Kaplan Executive Function System - Trail Making performance

  3. Change in Delis-Kaplan Executive Function System Color Word Interference performance [Visit 1 and Visit 5 (approx. 3 weeks apart)]

    Change in Delis-Kaplan Executive Function System - Color Word Interference performance

  4. Change in Wechsler Digit Span performance [Visit 1 and Visit 5 (approx. 3 weeks apart)]

    Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance

  5. Change in Wechsler Picture Span performance [Visit 1 and Visit 5 (approx. 3 weeks apart)]

    Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance

Secondary Outcome Measures

  1. Change in Oral Word Reading Fluency performance [Visit 1 and Visit 5 (approx. 3 weeks apart)]

    Change in Oral Word Reading Fluency performance

  2. Change in Math Fluency performance [Visit 1 and Visit 5 (approx. 3 weeks apart)]

    Change in Mathematics Fluency performance

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55454

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Jeffrey R Wozniak, Ph.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeff Wozniak, Professor, University of Minnesota
ClinicalTrials.gov Identifier:
NCT05456321
Other Study ID Numbers:
  • PSYCH-2022-30910
First Posted:
Jul 13, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders

Study Results

No Results Posted as of Aug 8, 2022