ADHD - Combined TypeNCT06512974
NeuroTrainer Cognitive Training For Academic Focus
A study testing NeuroTrainer in people with ADHD - Combined Type and ADHD Predominantly Inattentive Type, run by NeuroTrainer at 3 sites in United States.
Trial summary
This clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD - Combined Type, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- What is being tested?
- NeuroTrainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2024to 28 Feb 2026
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnostic criteria met ADHD for any ADHD presentation type, with severity ratings of subthreshold, moderate or severe
- Estimated IQ of 80 or greater
- Between 11-17 years of age
Who cannot join
- Presence of suicidality
- Presence of psychotic disorders
- Visual or hearing impairment
- Presence of severe depression
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Julie Schweitzer, Ph.D. contact
United States3 sites, 3 recruiting
- Recruiting
One City Schools
Madison, Wisconsin, 53713
Jeremy Clements, 608-790-2829, jclements@onecityschools.org
Jeremy Clements
- Recruiting
Marquette Senior High School
Marquette, Michigan, 49855
Brandon Wheeler, 906-225-5353, brwheeler@mapsnet.org
Jeff Nyquist, Ph.D.
- Recruiting
Westside High School
Omaha, Nebraska, 68114
Jay Dostal, Ed.D., 402-343-2600, dostal.jay@westside66.net
Sarah Anderson
About this study
Official title: A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties
This clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties.
Read the detailed description
The goal of this clinical trial is to test the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control function in students with and without attention-related difficulties. The main questions it aims to answer are (1) does NeuroTrainer improve attentional and executive control function, (2) does NeuroTrainer engage the target of ADHD inattention symptoms by identifying the target and demonstrating proximal changes in it, and (3) does NeuroTrainer demonstrate transfer of skill with improvement in academic behaviors. Researchers will compare students who use NeuroTrainer to a control condition to see if the NeuroTrainer intervention produces significant improvements.
Participants in the intervention group will engage in virtual reality (VR) sessions which include physical activity and cognitive training. Cognitive training will maximize time at performance thresholds and optimize for variability in task dynamics and demands.
- Conditions
- ADHD - Combined Type, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- Being tested
- NeuroTrainer
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroTrainerBehavioural
Virtual reality based cognitive training
| Study group | Role | What they receive |
|---|---|---|
| NeuroTrainer Intervention | Experimental | The NeuroTrainer intervention involves using a VR-based cognitive training program designed to improve attention and executive function in students with ADHD. Participants will engage in 30-minute sessions, approximately three times a week for 12 weeks, performing game-like tasks that integrate physical activity and adapt to their performance level. Receives: Behavioral: NeuroTrainer |
| Control Condition | No intervention | The control condition involves students receiving standard educational interventions without the use of NeuroTrainer. These activities include regular classroom instruction and typical academic tasks designed to support learning, without the additional cognitive training provided by the VR program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox Flanker Inhibitory Control and Attention Test (RT)
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the reaction time (RT) outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT)
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct)
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the percent correct outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Dimensional Change Card Sort Test (% Correct)
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the percent correct outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Dimensional Change Card Sort Test (Omissions)
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the omissions outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Dimensional Change Card Sort Test (RT)
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the response time (RT) outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Dimensional Change Card Sort Test (IIV-RT)
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox List Sorting Working Memory Test
This test serves as an evaluation of an individual's working memory capabilities. Participants will be presented with different stimuli visually and audibly, and they will be asked to recall and sequence them accordingly. The test takes approximately 7 minutes to complete.
Measured: Week 1, Month 2, Month 3, Month 9
NIH Toolbox Pattern Comparison Processing Speed Test
This is an assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. The test takes approximately 4 minutes to complete.
Measured: Week 1, Month 2, Month 3, Month 9
Secondary outcomes (3)
ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale
The investigators will assess the symptoms of ADHD by utilizing the parent and teacher ADHD Rating Scale-5 (ADHD:RS-5) Inattention Subscale, using two academic teachers and one parent for each participant. This 9-item subscale is specifically designed to evaluate the core ADHD symptoms of Inattention. By incorporating the perspectives of both teachers and parents, the investigators aim to obtain a comprehensive understanding of the participants' ADHD symptoms across settings. ADHD:RS-5: will be completed by prior school year teachers if the student has been in the class for less than 2 months. Higher scores represent a higher frequency of symptoms and this a worse outcome. For each item, "0" is the minimum and "3" is the maximum value.
Measured: Week 1, Month 2, Month 3, Month 9
ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale
The investigators will assess the symptoms of ADHD by utilizing the parent and teacher ADHD Rating Scale-5 (ADHD:RS-5) Impulsivity/Hyperactivity Subscale, using two academic teachers and one parent for each participant. This 9-item subscale is specifically designed to evaluate the core ADHD symptoms of Impulsivity/Hyperactivity. By incorporating the perspectives of both teachers and parents, the investigators aim to obtain a comprehensive understanding of the participants' ADHD symptoms across settings. ADHD:RS-5: will be completed by prior school year teachers if the student has been in the class for less than 2 months. Higher scores represent a higher frequency of symptoms and this a worse outcome. For each item, "0" is the minimum and "3" is the maximum value.
Measured: Week 1, Month 2, Month 3, Month 9
Academic Performance Rating Scale (APRS)
The 19-item Academic Performance Rating Scale (APRS; DuPaul et al.,1991) evaluates student academic performance and is ecologically valid due to (1) assessing in real classroom environments, mirroring academic challenges and behaviors, (2) evaluated by teachers who gain insights into students' academic performance beyond standard tests, and (3) encompassing aspects of academic abilities including behavior, productivity, and work accuracy. This scale has a high test-retest reliability (2-week test-retest=.93-.95; α=.94-.95). Higher scores indicate better academic functioning and impulse control in school. For each item, "1" is the minimum and "5" is the maximum value.
Measured: Week 1, Month 2, Month 3, Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Sep 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Combined TypeStudies 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
- This study will evaluate the efficacy of NeuroTrainer cognitive training for improving attention and executive function in students with ADHD and sub threshold ADHD, divided into intervention and control groups. Participants, aged 11-17, will be randomly assigned to use NeuroTrainer or receive standard educational activity. Primary outcomes include attention and executive function improvements, while secondary outcomes assess ADHD symptoms and academic performance. Data will be collected at baseline, midpoint, post-intervention and 6-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroTrainer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Davis
- Responsible party
- Principal investigator, Jeff Nyquist, NeuroTrainer
- Investigators
- Jeff Nyquist, Ph.D., Principal investigator, NeuroTrainer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512974
- Sponsor's protocol ID
- 1R43MH135599-01A1
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties
- ClinicalTrials.gov ID
- NCT06512974
- Acronym / sponsor ID
- 1R43MH135599-01A1
- Conditions
- ADHD - Combined Type, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- NeuroTrainerIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Davis
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 22 Jul 2024 (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 clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties.
Detailed description
The goal of this clinical trial is to test the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control function in students with and without attention-related difficulties. The main questions it aims to answer are (1) does NeuroTrainer improve attentional and executive control function, (2) does NeuroTrainer engage the target of ADHD inattention symptoms by identifying the target and demonstrating proximal changes in it, and (3) does NeuroTrainer demonstrate transfer of skill with improvement in academic behaviors. Researchers will compare students who use NeuroTrainer to a control condition to see if the NeuroTrainer intervention produces significant improvements.
Participants in the intervention group will engage in virtual reality (VR) sessions which include physical activity and cognitive training. Cognitive training will maximize time at performance thresholds and optimize for variability in task dynamics and demands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will evaluate the efficacy of NeuroTrainer cognitive training for improving attention and executive function in students with ADHD and sub threshold ADHD, divided into intervention and control groups. Participants, aged 11-17, will be randomly assigned to use NeuroTrainer or receive standard educational activity. Primary outcomes include attention and executive function improvements, while secondary outcomes assess ADHD symptoms and academic performance. Data will be collected at baseline, midpoint, post-intervention and 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| NeuroTrainer Intervention | Experimental | Behavioral: NeuroTrainerThe NeuroTrainer intervention involves using a VR-based cognitive training program designed to improve attention and executive function in students with ADHD. Participants will engage in 30-minute sessions, approximately three times a week for 12 weeks, performing game-like tasks that integrate physical activity and adapt to their performance level. |
| Control Condition | No intervention | –The control condition involves students receiving standard educational interventions without the use of NeuroTrainer. These activities include regular classroom instruction and typical academic tasks designed to support learning, without the additional cognitive training provided by the VR program. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnostic criteria met ADHD for any ADHD presentation type, with severity ratings of subthreshold, moderate or severe
- Estimated IQ of 80 or greater
- Between 11-17 years of age
Key exclusion criteria (4 listed)
- Presence of suicidality
- Presence of psychotic disorders
- Visual or hearing impairment
- Presence of severe depression
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 |
|---|---|---|
| NeuroTrainerVirtual reality based cognitive training | Behavioural | NeuroTrainer Intervention |
Primary outcome
NIH Toolbox Flanker Inhibitory Control and Attention Test (RT)
Time frame: Week 1, Month 2, Month 3, Month 9
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the reaction time (RT) outcome from this assessment.
NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT)
Time frame: Week 1, Month 2, Month 3, Month 9
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.
NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct)
Time frame: Week 1, Month 2, Month 3, Month 9
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the percent correct outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (% Correct)
Time frame: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the percent correct outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (Omissions)
Time frame: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the omissions outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (RT)
Time frame: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the response time (RT) outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (IIV-RT)
Time frame: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.
NIH Toolbox List Sorting Working Memory Test
Time frame: Week 1, Month 2, Month 3, Month 9
This test serves as an evaluation of an individual's working memory capabilities. Participants will be presented with different stimuli visually and audibly, and they will be asked to recall and sequence them accordingly. The test takes approximately 7 minutes to complete.
NIH Toolbox Pattern Comparison Processing Speed Test
Time frame: Week 1, Month 2, Month 3, Month 9
This is an assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. The test takes approximately 4 minutes to complete.
3 secondary outcomes
ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale
Time frame: Week 1, Month 2, Month 3, Month 9
ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale
Time frame: Week 1, Month 2, Month 3, Month 9
Academic Performance Rating Scale (APRS)
Time frame: Week 1, Month 2, Month 3, Month 9
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 19 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Julie Schweitzer, Ph.D. contact
Jeff Nyquist, Ph.D. principal investigator
NeuroTrainer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroTrainer in people with ADHD - Combined Type and ADHD Predominantly Inattentive Type, run by NeuroTrainer at 3 sites 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 3 inclusion and 4 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 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 Jeff Nyquist, Ph.D. (9062507356, jnyquist@neurotrainer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Toolbox Flanker Inhibitory Control and Attention Test (RT) (time frame: Week 1, Month 2, Month 3, Month 9). The study lists 9 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 19 Jun 2025.