CIFASD 5 tDCS and Cognitive Training

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05456321
Status
Recruiting

Conditions

  • Fetal Alcohol Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Active tDCS — DEVICE
    Active Transcranial Direct Current Stimulation (tDCS)
  • Cognitive Training — BEHAVIORAL
    Computerized Cognitive Training
  • Sham tDCS — DEVICE
    Sham Transcranial Direct Current Stimulation (tDCS)

Study Details

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).

Key Dates

Start date
Nov 10, 2022
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cognitive Training and Active tDCS
    5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).
  • Sham Comparator: Cognitive Training and Sham tDCS
    5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55454
Jeffrey R Wozniak, Ph.D.

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