Guided ADHD Therapy for Managing the Extent and Severity of Symptoms (GAMES)

Lumos Labs

Status

Completed

Conditions

ADHD

Treatments

Device: Control Therapy

Device: ADHD Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05296473

CIP-013

Details and patient eligibility

About

The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).

Enrollment

560 patients

Sex

All

Ages

22 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects 22-55 years of age
Male or female
Confirmed ADHD diagnosis, combined or inattentive type, at Screening based on DSM-5 criteria and established via the MINI-Adult, administered by a trained clinician
Baseline score on the clinician-rated ADHD-RS total score ≥28
Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening; or, if undergoing pharmacological treatment, must be willing and appropriate (i.e., not optimally treated in the Investigator's judgement or having issues with tolerability) to wash out of current regimen
Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
Ability to understand and speak English, follow written and verbal instructions (English), as assessed by the PI and/or Study Coordinator, and give informed consent (English)
Have ability to connect wireless devices to a functional wireless network on a daily basis
Ability to comply with all the testing and study requirements

Exclusion criteria

Current, controlled (requiring restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-Adult and subsequent clinical interviewing, with significant symptoms including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
Patients who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine, viloxazine)
Have previously been assessed by TOVA for potential enrollment in a clinical trial.
Have previously used a videogame-like digital therapy (e.g., Akili EndeavorRxTM) OR Within the last three years, have used a cognitive or brain training platform (e.g., Peak, Brain HQ, Lumosity, Atentiv) for more than two weeks duration
Known sensitivity to playing video games, such as headaches, dizziness, nausea.
Initiation within the last 4 weeks of behavioral therapy or neurofeedback, or planned initiation during the study. Patients who have been in behavior therapy or neurofeedback consistently for more than 4 weeks may participate provided their routine is unchanged during the course of the study. Patients planning on changing or initiating behavior therapy or neurofeedback during the course of the study will be excluded.
Patient is currently considered a suicide risk in the opinion of the Investigator, as measured by C-SSRS at screening (i.e., score of 4 or 5 on C-SSRS)
Motor condition (e.g., physical deformity of the hands/arms; protheses) that prevents game playing as observed by the Investigator
Recent history (within the past 12 months) of suspected alcohol or substance abuse or dependence
Positive urine drug screen
History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy
Visual acuity that cannot be corrected that prevents or negatively impacts game playing as observed by the Investigator
Any use of psychoactive drugs (other than stimulant) that in the opinion of the Investigator may confound study data/assessments
Has participated in a clinical trial within 90 days prior to screening
Has a family member or close friend/associate also enrolled/currently participating in the same study
Any other condition that in the opinion of the Investigator may confound study data/assessments