Medication for Tourette's Syndrome & Tics (D1AMOND Study)
Cortica locations in Northern California (Marin) and Southern California (Glendale) surpassed program-wide enrollment goals in Emalex Biosciences' Phase 3 trial assessing the safety and efficacy of ecopipam, a selective D1 dopamine receptor blocking agent for the treatment of tics in adults and children with Tourette's Syndrome.
Medication for Autism & Irritability (Penguin Study)
Cortica locations in Northern California (Marin) and Southern California (Glendale) were top recruiters globally for Acadia Pharmaceuticals’ Phase 2 trial. The study assessed the safety and efficacy of a highly selective antipsychotic, pimavanserin, for the treatment of irritability associated with Autism Spectrum Disorder in children and adolescents.
Medication for Autism & Social Challenges (Yamo Study)
Cortica’s Northern California location (Marin) supported the completion of Yamo Pharmaceutical’s phase II trial evaluating their novel medication, L1-79, to support social communication interactions in autistic individuals aged 12-21 years.
Medication for Autism & Irritability via the Gut Microbiome (Tapestry Study)
Cortica locations in Northern California (Marin) and Southern California (Westlake Village) finished in first place on the national leaderboard for participant enrollment in Axial Therapeutics’ phase 2b trial. This study assessed the safety and efficacy of the medication AB-2004, which aims to reduce irritability and anxiety experienced by autistic individuals aged 5-17 years old.
Eye-Tracking to Measure Treatment Progress (MEASURE-ASD Study)
EarliTec Diagnostics collaborated with Cortica for a clinical research study to investigate whether an innovative eye-tracking device, called EarliPoint, can be used as a treatment monitoring tool to help detect developmental changes in children with ASD. Cortica locations in Northern California (Marin) and Southern California (Glendale, Westlake Village, Torrance) were the first sites to reach their enrollment capacity for this study.
Digital Therapeutic for ADHD (GAMES Primary Study)
Cortica Scottsdale contributed over 100 enrolled participants in the Lumos Labs GAMES Study which aimed to evaluate the safety and efficacy of an at-home, game-based digital therapy aimed to support adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Virtual Reality to Support Social Communication Skill-Building (FloreoVR Pilot)
Cortica locations across Southern California (Torrance, Irvine, Laguna Niguel, Carlsbad, and San Diego) enrolled all participants in the Floreo pilot study which resulted in receipt of FDA’s Breakthrough Device designation and acceptance into FDA’s Total Product Life Cycle Advisory Program (TAP Program). Due to Cortica Innovation Network’s successful efforts in this pilot study, FloreoVR’s pivotal study is currently enrolling exclusively at 11 Cortica locations nationwide.
Prescription Video Game for ADHD Treatment (EndeavorRx®)
Cortica locations in Northern California (Marin) and Southern California (Westlake Village) topped the leaderboard for the age expansion study for EndeavorRx®, the first prescription video game treatment for attention challenges. Cortica’s contribution to this study supported Akili Therapeutics’ procurement of the FDA Label Expansion of EndeavorRx® to cover ages 8-17 years.
Pediatic Body-Brain Trainer (pediBBT)
Partnering with UCSF, the Cortica Innovation Network published a pilot study using a cognitive-physical video game to enhance attention in children ages 7 to 12. During the 8-week course of digital treatment, researchers observed that 95 percent of participants used the game as directed and there were significant improvements in both parent-reported behavior and assessments of attention at the end of the study and at one year post-treatment. This proof-of-concept study emphasized the need for future research into using video games for attention improvement.
Observational Study for Sensory Processing in Neurodevelopment (SPIN Study)
Cortica Marin partnered with the University of California, San Francisco (UCSF) to enroll 190 participants into an NIH-funded observational study involving extensive direct cognitive and sensory assessments, questionnaires, and 3T brain MRI scanning to create a robust set of data on the unique sensory processing experiences of individuals with neurodevelopmental concerns. A multitude of publications have resulted from this dataset, and as a result, a 7T MRI longitudinal follow-up study is underway.
Cranial Electrostimulation for Behavioral Regulation
The Cortica Innovation Network published an open-label study using Cranial Electrostimulation to support behavioral regulation in neurodivergent individuals. This initial study enrolled 263 participants and showed a significant reduction in sensory sensitivity, anxiety, emotion dysregulation, insomnia, and constipation in participants following 4 weeks of CES treatment. CES treatment is now offered as a neuromodulation therapy to Cortica patients.