Fetal Alcohol Spectrum DisordersNCT05456321
CIFASD 5 tDCS and Cognitive Training
A study testing Active tDCS and Cognitive Training in people with Fetal Alcohol Spectrum Disorders, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Active tDCS and Cognitive Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Jeffrey R Wozniak, Ph.D., jwozniak@umn.edu
About this study
Official title: tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
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).
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Active tDCS, Cognitive Training, Sham tDCS
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Active Transcranial Direct Current Stimulation (tDCS)
Cognitive TrainingBehavioural
Computerized Cognitive Training
Sham tDCSDevice
Sham Transcranial Direct Current Stimulation (tDCS)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training and Active tDCS | Active comparator | 5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions). Receives: Device: Active tDCS; Behavioral: Cognitive Training |
| Cognitive Training and Sham tDCS | Sham comparator | 5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions). Receives: Behavioral: Cognitive Training; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Continuous Performance Test performance
Change in Continuous Performance Test performance
Measured: After each study visit (approx. bi-weekly) for the duration of the study (10 visits, approx. 5 weeks)
Change in Delis-Kaplan Executive Function System -Trail Making performance
Change in Delis-Kaplan Executive Function System - Trail Making performance
Measured: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System Color Word Interference performance
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Measured: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Digit Span performance
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Measured: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Picture Span performance
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
Measured: Visit 1 and Visit 5 (approx. 3 weeks apart)
Secondary outcomes (2)
Change in Oral Word Reading Fluency performance
Change in Oral Word Reading Fluency performance
Measured: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Math Fluency performance
Change in Mathematics Fluency performance
Measured: Visit 1 and Visit 5 (approx. 3 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start10 Nov 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized allocation to active tDCS or placebo (sham tDCS).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Wozniak, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456321
- Sponsor's protocol ID
- PSYCH-2022-30910
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD
- ClinicalTrials.gov ID
- NCT05456321
- Acronym / sponsor ID
- PSYCH-2022-30910
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomized allocation to active tDCS or placebo (sham tDCS).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training and Active tDCS | Active comparator | Device: Active tDCS, Behavioral: Cognitive Training5 sessions of computerized executive functioning training - plus active tDCS (also 5 sessions). |
| Cognitive Training and Sham tDCS | Sham comparator | Behavioral: Cognitive Training, Device: Sham tDCS5 sessions of computerized executive functioning training - plus sham tDCS (also 5 sessions). |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSActive Transcranial Direct Current Stimulation (tDCS) | Device | Cognitive Training and Active tDCS |
| Cognitive TrainingComputerized Cognitive Training | Behavioural | Cognitive Training and Active tDCS, Cognitive Training and Sham tDCS |
| Sham tDCSSham Transcranial Direct Current Stimulation (tDCS) | Device | Cognitive Training and Sham tDCS |
Primary outcome
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)
Change in Continuous Performance Test performance
Change in Delis-Kaplan Executive Function System -Trail Making performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System - Trail Making performance
Change in Delis-Kaplan Executive Function System Color Word Interference performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Delis-Kaplan Executive Function System - Color Word Interference performance
Change in Wechsler Digit Span performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Digit Span performance
Change in Wechsler Picture Span performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Wechsler Intelligence Scale for Children or Wechsler Adult Intelligence Scale Picture Span performance
2 secondary outcomes
Change in Oral Word Reading Fluency performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Change in Math Fluency performance
Time frame: Visit 1 and Visit 5 (approx. 3 weeks apart)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
Related trials for Fetal Alcohol Spectrum Disorders
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingPhase 2
FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
Recruiting
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Fetal Alcohol Spectrum Disorders
Recruiting
The Synchrony Study: Examining Music Training for Children With FASD
Fetal Alcohol Spectrum Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey R Wozniak, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and Cognitive Training in people with Fetal Alcohol Spectrum Disorders, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Wozniak, PhD (1-612-598-0041, jwozniak@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.