Substantial Clinical
Evidence Base

Science feature image

Skylar’s Run uses the proprietary, patent pending, Focus>Forward Modeling System (FFM) and the Brain to Computer Interface (BCI) in the treatment of ADHD. To date, the effectiveness of these core technologies were evaluated in eight studies with 337 children with ADHD. Five studies were randomized, controlled studies where participants either trained with the active treatment or were in the control group (control participants were either put on a waiting list or received other non-medication therapy options).

skylar-run-image

a substantial clinical evidence base

8 clinical studies with 337 children with ADHD. Of the 8 studies:

4 are on phase 2
are Phase II Randomized Controlled Studies
5 published
have been published
in Peer Reviewed
journals
4 are on phase 2
of the studies have been independently funded and conducted
The primary measure of treatment efficacy in these studies was the ADHD Rating Scale. The ADHD-RS is widely recognized by Key Opinion Leaders and regulatory authorities (FDA) as a gold standard primary measure of treatment efficacy for ADHD.
Across three (3) studies,
Significant symptom improvement vs. control group
Skylar’s Run uses the proprietary, patent pending, Focus>Forward Modeling System (FFM) and the Brain to Computer Interface (BCI) in the treatment of ADHD chart
Significant improvement in clinician’s global impression of disease severity
Significant improvement in clinician’s global impression of disease severity Chart

Across four (4) studies,

Maintenance of Effect
Significant symptom improvement for at least 6 months following treatment initiation

Significant symptom improvement for at least 6 months following treatment initiation Chart

In Phase 1 & 2 Clinical Trials

There were no serious adverse events seen in any clinical trials of Skylar’s Run. All adverse events were reported as mild to moderate and transient. No treatment-emergent adverse events led to treatment discontinuation and no participants reported lasting or irreversible effects following completion.

The most common side effects reported in all the clinical studies were headache, frustration, dizziness, nausea, motion sickness, and eye strain. 

In a clinical study of children ages 6-12 years-old (n=172)
  • A total of eleven (6.4 percent) participants reported at least one adverse event
  • Headache was the most common complaint followed by dizziness
  • There were no discontinuations due to treatment-emergent adverse events

Children did not report the side effects that children commonly experience with ADHD medications such as trouble sleeping, weight loss, or decreased appetite

References
  1. Lim CG, Poh XWW et al (2019) A randomized controlled trial of a brain-computer interface-based attention training program for ADHD. PloS ONE 14 (5)
  2. McDermott F, Rose M et al (28 Jan 2016) A novel feed-forward modeling system leads to sustained improvements in attention and academic performance Journal of Attention Disorders
  3. Lim CG, Lee TS et al (2010) Effectiveness of a brain-computer interface-based program for the treatment of ADHD: A pilot study. Psychopharm Bulletin 43 (1)
  4. McDermott F, Rose M et al (unpublished) Brain-to-computer interface training program improves attention and academic achievement.
  5. Lim CG, Lee TS et al (2012) A brain-computer interface-based attention training program for treating attention deficit hyperactivity disorder PloS ONE 7(10):e46692
  6. Atentiv data on file