Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Randomized, Controlled, Parallel-group, Intervention Study to Assess an At-home, Game-based Digital Therapy for Treating Adult Patients With Attention-Deficit/Hyperactivity Disorder

Lumos Labs, Inc.13 sites in 1 country560 target enrollmentMay 5, 2022

ConditionsADHD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ADHD
Sponsor: Lumos Labs, Inc.
Enrollment: 560
Locations: 13
Primary Endpoint: Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

May 5, 2022

End Date

March 12, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lumos Labs, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)

Time Frame: Study Day 0 to Study Day 63

The TOVA is a standardized, computerized, continuous performance test (CPT). The TOVA Attention Comparison Score (ACS) is a comparison of a subject's scores to scores from a normative ADHD population. A score of \< 0 indicates a subject's performance is similar to that of the normative ADHD population, with a lower score indicating a more severe ADHD profile. A positive change on the TOVA ACS from Day 0 to Day 63 indicates improvement.

Secondary Outcomes

Clinical Global Impression Scale - Improvement (CGI-I)(at Study Day 63)
Cambridge Brain Sciences Spatial Span(Study Day 0 to Study Day 63)
ADHD-RS-5 Inattention Subscale with Adult Prompts(Study Day 0 to Study Day 63)
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles(Study Day 0 to Study Day 63)
Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)(Study Day 0 to Study Day 63)
Cambridge Brain Sciences Token Search(Study Day 0 to Study Day 63)