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NCT Number: NCT07839013

Brain Function and Cognitive Control Training in Children With Obsessive-Compulsive Symptoms

The goal of this clinical trial is to learn about brain function and cognition in children ages 8-12 who have subclinical obsessive-compulsive symptoms (OCS), such as unwanted thoughts or repetitive behaviors. The study will also examine whether patterns of brain activity are related to how children respond to cognitive training.

The main questions this study aims to answer are:

* Are there different patterns of brain activity related to cognitive control among children with OCS? * Are these patterns related to differences in OCS or cognition? * Can brain activity before training help predict changes in cognitive control or OCS severity after cognitive training?

Participants will:

* Complete clinical interviews, questionnaires, and tests of cognition. * Have a magnetic resonance imaging scan while completing a cognitive control task. * Complete video-game-based cognitive training on an iPad for about 25 minutes a day, 5 days a week, for 4 weeks. * Complete another set of clinical interviews and questionnaires after the training.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 8 to 12 years at the time of consent (i.e., 8.00 - 12.99 years).
  • Will have definite obsession(s) and/or compulsion(s)
  • NO current or lifetime history of meeting DSM-5 criterion B for OCD.
  • Not on psychotropic medication (either treatment-naïve or free of psychotropic medication for at least one month) or on stable medication regime for ADHD (e.g., stimulants).
  • Capacity to provide written informed assent by the participants and permission by the parent/guardian.

Exclusion criteria

  • DSM-5 current major depressive disorder.
  • DSM-5 current or lifetime diagnosis of OCD, PTSD, substance/alcohol abuse, psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder.
  • Current or lifetime history of a major medical or neurological problem (e.g., unstable hypertension, seizure disorder, major head trauma).
  • Active suicidal ideation with some intent to act.
  • Presence of metallic device (ferromagnetic implants or dental braces).
  • Females who are pregnant or nursing.
  • Wechsler Abbreviated Scale of Intelligence II Full-scale IQ <80.

Treatment and study plan

Cognitive Control Training

Device

Digital, at-home cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week) for 4 weeks. Styled as a child-friendly video game, AKL-T01 cognitive training taps skills like focused attention, response inhibition, and working memory using a series of games with individually titrated difficulty to engage cognitive control processes.

Other names: AKL-T01, Akili

Primary outcomes

  1. NIH Toolbox Cognition Battery

    Time frame: Baseline, post-cognitive training (4 weeks)

    Standardized Fluid Cognition Composite Score derived from the NIH Toolbox Cognition Battery. Scores are norm-referenced with a mean of 100 and standard deviation of 15; higher scores indicate better cognitive functioning.

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Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: AKILI - OCS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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