Background:
Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions.
Objective:
To see if virtual reality-based games help improve thinking skills and brain function in children with ADHD.
Eligibility:
Children aged 8 to 16 years with ADHD.
Design:
We will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Participants may have an MRI scan of the brain. They may also have magnetoencephalography (MEG) and electroencephalography (EEG) scans, which record brain activity using sensors placed near or on the head. These scans are optional.
Participants will receive a set of virtual reality games. The set includes 3 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks.
The parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, and working memory.
Participants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played.
The brain scans may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.
Children must provide informed assent and parents must provide informed consent to participate in the study.
Any sex assigned at birth, or race/ethnicity.
Aged between 8 and 16 years of age, including all months leading up to age 17. For the pilot only, the minimum age was 10 years (i.e., pilot participants were aged 10 to 16 years, including all months leading up to age 17).
Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation).
Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)
History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
Known to be pregnant.
Parallel
Non-adaptive Floreo VR control
BehavioralThe control intervention uses the same Floreo VR training modules, session schedule, headset, and spaceship themed environment as the active intervention. The only difference is that module difficulty is capped at a low level and does not continue to adapt to the child's performance, so demands remain low throughout training. The control training is also completed at home under the supervision of a parent or caregiver, and the two versions are otherwise indistinguishable to families and study staff.
Floreo Virtual Reality application
BehavioralFloreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain relevant to ADHD (inhibitory control, working memory, and processing speed). A fourth module targeting temporal processing was used in the Phase I pilot only and is not included in the Phase II trial. The demands of the training intervention adapt to the subject's practice-driven improvements in performance. Specifically, when the subject is deemed to perform adequately well at a given level of difficulty, the training adapts by presenting a more challenging difficulty. This adaptation to the subject's performance is designed to allow for continued incremental improvements in the trained domains. The VR games take place in a spaceship themed environment. The VR training is designed to be used at home, under the supervision of a parent.
ADHD-RS-5 inattention sub-scale.
The ADHD-RS-5 is a rating scale based on the diagnostic criteria for ADHD as described in the DSM-5. Inattention symptoms are one of two key symptom domains for ADHD, and the target of the present intervention.
Stop signal reaction time on the Stop Signal task (inhibitory control)
Computerized neuropsychological assessment of inhibitory control
Temporal deviation on a temporal reproduction task
Computerized neuropsychological assessment of motor-timing. This measure was collected in the Phase I pilot only and is not administered in the Phase II randomized trial.
Number of correct responses on the Dot Matrix task
Computerized neuropsychological assessment of working memory
Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.
Computerized neuropsychological assessment of processing speed
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