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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)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
1,379 Previous Clinical Trials
1,588,422 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific criteria for individuals to qualify as participants in this research?

"70 minors aged between 8 and 17 with fetal alcohol syndrome are eligible to enter this experiment. Candidates must provide evidence of significant prenatal alcohol exposure, as well as an appropriate FASD diagnosis. In addition, they need a parent or legal guardian who is able to give their informed consent for the study's participation."

Answered by AI

Are there opportunities to join this clinical investigation at present?

"According to the details presented on clinicaltrials.gov, this particular trial has concluded recruitment since its last update on October 3rd 2022. Nevertheless, 12 other trials are actively recruiting volunteers at present."

Answered by AI

Is it possible for geriatric patients to join the experiment?

"This clinical trial requires participants to be between 8 and 17 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CIFASD 5 tDCS and Cognitive Training
Jeff Wozniak 2022. "CIFASD 5 tDCS and Cognitive Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05456321.
~47 spots leftby May 2027
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