An interventional study of ADHD Therapy and Control Therapy in ADHD, sponsored by Lumos Labs, Inc.. Completed at 13 sites in United States. Open to participants aged 22 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Lumos Labs, Inc. · Not applicable, Interventional, and Treatment
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).
Lumos Labs, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: ADHD Therapy
Device: Control Therapy
investigational game-play therapy
control game-play therapy
Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
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.
Time frame: Study Day 0 to Study Day 63
ADHD-RS-5 Inattention Subscale with Adult Prompts
The ADHD-RS-5 with Adult Prompts is an 18-item, clinician-administered questionnaire that rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-5. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The first 9 items assess inattention symptoms and the last 9 items assess hyperactive-impulsive symptoms. Each subscale produces a sub-scale score ranging from 0-27. A higher subscale score indicates more severe ADHD symptoms and behaviors. A negative change on the inattention subscale from Day 0 to Day 63 indicates improvement.
Time frame: Study Day 0 to Study Day 63
Cambridge Brain Sciences Token Search
Token Search is a computerized task designed to assess working memory. In Token Search, subjects identify the location of a hidden token in a set of boxes while remembering where previous tokens have been found. Correctly finding a token in every box will increase difficulty level in the form of a new puzzle with an increased number of boxes. Performance is indicated by the average number of tokens found. A positive change in score on the Token Search task from Day 0 to Day 63 indicates improvement.
Time frame: Study Day 0 to Study Day 63
Cambridge Brain Sciences Spatial Span
Spatial Span is a computerized task designed to assess spatial short-term memory and based on the Corsi Block tapping task. In Spatial Span, subjects are shown a sequence of flashing boxes and have to repeat the sequence. Sequence lengths increase with correct answers. Performance is indicated by the average number of boxes remembered during the task. A positive change in score on the Spatial Span ask from Day 0 to Day 63 indicates improvement.
Time frame: Study Day 0 to Study Day 63
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles
The BRIEF-A is composed of 75 items within nine non-overlapping theoretically and empirically derived clinical scales that measure various aspects of executive functioning. Each item is rated as either 1 (never), 2 (sometimes), or 3 (often). A reduction in score from Day 0 to Day 63 indicates improvement.
Time frame: Study Day 0 to Study Day 63
Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)
The WFIRS-S is a validated rating scale used to capture functional difficulties in the lives of individuals with ADHD in 7 domains. Each item is scored on a 4-point scale ranging from 0 (Never or not at all) to 3 (Very often of very much). A reduction in score from Day 0 to Day 63 indicates improvement.
Time frame: Study Day 0 to Study Day 63
Clinical Global Impression Scale - Improvement (CGI-I)
The Clinical Global Impression Scale-Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow-up to the overall clinical condition at baseline. The CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). A score of 1 (very much improved) or 2 (much improved) or 3 (minimally improved) would indicate overall improvement of ADHD severity.
Time frame: at Study Day 63
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Lumos Labs, Inc.