April 14, 2016

(SAN FRANCISCO, CA) Researchers from Posit Science Corporation announced results from an initial study of its brain exercises used by children with attention deficit hyperactivity disorder (ADHD).  The group of children completing 30 hours of the Posit Science brain exercises showed steady and significant improvements on the study’s primary outcome measure, the ADHD rating scale (RS IV, a parent-reported symptom severity measure), over the course of the six-month study period and in the six-month post-study follow-up. The results were significant both against baseline (within group) and against the control group, which engaged in 30 hours of video game play. Improvements were also noted on secondary measures. The significance of these findings were discussed today in Washington, DC, at the World Bank’s Global Mental Health Summit, by lead investigator Dr. Jyoti Mishra. The results were published this week in the journal Translational Psychiatry, published by Nature.

“These initial study results are exciting for several reasons,” said Dr. Mishra, Assistant Professor of Neurology and Psychiatry at the University of California San Francisco, and scientist affiliate at the Brain Plasticity Institute of Posit Science Corporation. “The data indicates that it is feasible to address ADHD with a non-pharmaceutical intervention, that positive behavioral and cognitive outcomes can be obtained, that brain exercises specifically designed for ADHD outperformed the video games used as an active control, and that this type of new digital therapy can be deployed in low-to-middle income homes with remote monitoring.”

The Centers for Disease Control and Prevention estimates that nearly 10 percent of children are diagnosed with ADHD. Such children display poor performance in everyday activities requiring attention, memory and goal management skills, and are at higher risk for failure (and dropout) at school, addiction, criminality and other negative quality-of-life outcomes.

The paper’s authors note that stimulant medications are the standard of care. Although they show high efficacy in the short term (2-3 months), limitations from medications include minimal long-term benefit, non-specific amplification of attention to both important and unimportant information, and accumulation of drug-related side effects.

The 31-person, double-blind, randomized controlled trial was conducted under the supervision of Dr. Rajesh Sagar, child psychiatry expert at the All India Institute of Medical Sciences in New Delhi, India. The mean age of participants was 12 years, and 15 of the 31 children were on medication before and during the study. Through randomization, 10 children were assigned to a control group using video games and 21 were assigned to the novel intervention of computerized brain exercises developed at Posit Science. Children engaged in the intervention or control activity for a total of 30 hours over a period that extended as long as six months (at a frequency of 3-5 times per week and 30 minutes per session). A majority (52%) of children completely adhered to the 30-hour requirement for brain exercises, while the remainder partially adhered, including ten children who completed less than half of the 30 hour training (1-13 hours, mean 4.5± 3.6 hours).

In addition to comparing the brain exercise intervention group against an active (video game) control, researchers compared the two groups to an additional group of 30 healthy children, without ADHD, drawn from the local community in New Delhi. Notably, at the six-month follow-up evaluations, there was no significant difference on the primary outcome measure between the healthy group and the group that had completed the brain exercises, suggesting renormalization of behaviors. The group who completed the brain exercises (as compared to the control group) had effects that were moderate in size and clinically significant both after training and at the six-month follow-up.

Four secondary cognitive measures were also used.  The brain exercise group significantly improved, as compared to the control, on both the response inhibition measure and Stroop interference, a measure of executive function.  A trend toward improvement, which did not reach significance, was noted on the two other secondary measures: sustained attention and short-term memory span.  An additional secondary measure, CGI, a generic measure of mental illness not specific to ADHD, was not found to be significantly affected by the intervention.

The brain exercises took a novel approach by focusing on the suppression of distractors (i.e., background noise) as part of improving focus and attention, in addition to challenging the user to attend to a target signal, which progressively becomes more difficult to discriminate. While some of the exercises were drawn from attention exercises currently included in BrainHQ (the commercially available online subscription exercise service from Posit Science), other brain exercises were specifically developed for this trial based on prior research.

“This is an important step in our research and development program aimed at bringing medicine-grade digital therapeutics to market, as a separate product line from our BrainHQ exercises for healthy people of all ages,” said Dr. Henry Mahncke, CEO of Posit Science.  “This is the first time software has been shown to be effective as a digital therapeutic, with clinically significant and persistent effects, in reducing reported behavioral symptoms of children with ADHD. Of course, additional research is both required and warranted before commercial distribution of new therapeutic offerings.”

Posit Science exercises and assessments have been shown to have benefits in some 120 peer-reviewed journal articles. Its current flagship commercial offering is BrainHQ, an online (and in-app) subscription service available to the public, with dozens of exercises shown in prior studies to improve standard measures of cognition (e.g., speed, attention, memory, executive function), as well as to generalize to gains in real-world measures and activities (e.g., health, mood, IADLs, driving, balance, gait, hearing). Posit Science sells both directly to consumers and through distribution partnerships with recognized global brands. Posit Science also has established research alliances with university-based researchers, foundations, government agencies, pharma and insurance companies. More information at www.BrainHQ.com