Evidence Summary

LumosityRx is a digital therapeutic recently cleared by the FDA for use by adults with ADHD. Its clearance was based on a large, rigorous clinical trial that showed improvements in attention, quality of life, and overall ADHD status.

Pivotal Clinical Trial Overview

The pivotal trial was called the GAMES study. The study design was what scientists call the "gold standard" of clinical research: a randomized, double-blind, sham-controlled trial.

Who was in the study?

560 adults between the ages of 22 and 55, all with a confirmed diagnosis of ADHD.

How was it designed?

Participants were randomly split into two groups: one group used LumosityRx, the other used a control (sham) program. Neither the participants nor the researchers knew who was in which group — this helps ensure fairness and accuracy. Participants were assessed before and after using their program for about 15 mins per day for 9 weeks.

Proven Results

Improved Attention

Participants who used LumosityRx showed a statistically significant improvement in attention compared to the control group. On average, their attention functioning improved by 1.1 points compared to only 0.3 points in the control group, as measured by the TOVA®, a test used to measure selective and sustained attention.

Why it matters: Participants didn't just improve at the games in their program - the improvements extended to a separate, objective measure of attention.

Primary Endpoint: Improvement in Attention chart showing Control at 0.3 and LumosityRx at 1.1

32.1%

Much Improved

Greater Clinical Improvement

Clinicians — who didn't know which program participants used — rated how much each person's ADHD improved at the end of the 9 weeks. The rating scale was known as the Clinical Global Impression-Improvement scale (CGI-I). An analysis of these ratings found there was superior clinical benefit for LumosityRx users compared to the control group. 32.1% of LumosityRx users were rated as "Much improved" on this scale.

Why it matters: This shows that LumosityRx had a measurable and positive effect on ADHD, as assessed by clinicians.

Better Quality of Life

People using LumosityRx reported improvements in their day-to-day lives — like how their ADHD impacts their focus, emotional balance, and productivity. The average improvement was +8.7 points on the Adult ADHD Quality of Life (AAQoL) questionnaire — a clinically validated measure.

Why it matters: This reflects that LumosityRx users experienced improvements that they could notice in their personal life, not just in a test.

+8.7

Points Improvement

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Indications for Use

LumosityRx was cleared by the FDA under the name "Prismira."

Indications for Use: Prismira is a digital therapeutic indicated to improve attention function in adults ages 22-55 years old with primarily inattentive or combined-type Attention Deficit and Hyperactivity Disorder (ADHD). Patients who engage with Prismira demonstrate improvements in a digitally assessed measure of sustained and selective attention, Test of Variables of Attention (TOVA), and may not display benefits in typical behavioral symptoms, such as hyperactivity. Prismira should be considered for use as part of a therapeutic program that may include clinician directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

Limitations: Prismira may not be appropriate for users with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device. Always consult with your healthcare provider before starting any new treatment. This information does not replace professional medical advice, diagnosis, or treatment.