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Device

tDCS + Cognitive Training for Fetal Alcohol Spectrum Disorders

N/A
Recruiting
Led By Jeffrey R Wozniak, Ph.D.
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 and visit 5 (approx. 3 weeks apart)

Summary

This trial is testing whether a cognitive training program, when combined with a non-invasive brain stimulation technique, can help improve thinking skills in children and adolescents with prenatal alcohol exposure.

Who is the study for?
This trial is for children and teens aged 8-17 with Fetal Alcohol Spectrum Disorders (FASD) due to heavy prenatal alcohol exposure. They need a parent or guardian to consent. It's not for those with substance abuse, other developmental disorders, serious psychiatric conditions affecting the brain, very low birthweight, or who can't have MRI or tDCS.
What is being tested?
The study tests if cognitive training combined with an active brain stimulation technique called transcranial direct current stimulation (tDCS) helps improve brain function in kids with FASD. Some participants will receive a placebo version of tDCS instead of the active treatment.
What are the potential side effects?
Possible side effects from tDCS may include mild discomfort at the electrode site on the scalp, itching, tingling during application, headache, fatigue and nausea. Most are temporary and resolve soon after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 and visit 5 (approx. 3 weeks apart)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 and visit 5 (approx. 3 weeks apart) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Continuous Performance Test performance
Change in Delis-Kaplan Executive Function System -Trail Making performance
Change in Delis-Kaplan Executive Function System Color Word Interference performance
+2 more
Secondary study objectives
Change in Math Fluency performance
Change in Oral Word Reading Fluency performance

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cognitive Training and Active tDCSActive Control2 Interventions
5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions).
Group II: Cognitive Training and Sham tDCSPlacebo Group2 Interventions
5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions).

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,573 Total Patients Enrolled
3 Trials studying Fetal Alcohol Spectrum Disorders
150 Patients Enrolled for Fetal Alcohol Spectrum Disorders
Jeffrey R Wozniak, Ph.D.Principal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
166 Total Patients Enrolled
3 Trials studying Fetal Alcohol Spectrum Disorders
166 Patients Enrolled for Fetal Alcohol Spectrum Disorders

Media Library

Active tDCS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05456321 — N/A
Fetal Alcohol Spectrum Disorders Research Study Groups: Cognitive Training and Active tDCS, Cognitive Training and Sham tDCS
Fetal Alcohol Spectrum Disorders Clinical Trial 2023: Active tDCS Highlights & Side Effects. Trial Name: NCT05456321 — N/A
Active tDCS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456321 — N/A
~39 spots leftby May 2027
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