Cupertino

Researchers are evaluating the use of HeadPulse data to observe brain activity in individuals aged 4 and older who have experienced a concussion, particularly focusing on sports team members due to their higher risk of injury. The study aims to validate HeadPulse as a digital tool that can objectively show when a brain remains affected despite the absence of symptoms, supporting safer decisions on return to play or normal activities. The study involves collecting HeadPulse data from participants who have been diagnosed with or are suspected to have a concussion or mild traumatic brain injury. Data will be gathered over approximately 30 days from enrollment to assess the time course of abnormalities and identify participants who may worsen after clearance to resume activities. Participants will provide data for about one month while researchers monitor brain activity through the HeadPulse device. The primary measurement is the evaluation of HeadPulse abnormalities over time and the proportion of subjects who experience worsening symptoms after they have been cleared to return to activities. This monitoring helps assess the potential of HeadPulse as an objective biomarker for concussion recovery.

Researchers are evaluating the safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. This post-approval study aims to confirm the safety of these lenses in the intended US patient population. Safety data from a previous MiSight 1 Day study will also be used to supplement this evaluation. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on children interested in wearing contact lenses for about 10 hours per day, 6 days per week. During this time, subjects will be monitored to assess the incidence of microbial keratitis and other safety outcomes. Throughout the study, children will undergo regular eye exams to check visual acuity and eye health, ensuring they remain free from infections or complications. Parent or guardian consent and assent from the child will be obtained, and medical records will be reviewed to track outcomes related to contact lens safety over the three-year period.

Researchers are evaluating the safety, feasibility, effectiveness, and lasting effects of non-invasive electrical vestibular stimulation (EVS) on balance and walking ability in healthy adults aged 18 to 100 years. This study focuses on improving balance and gait by stimulating the vestibular system, which helps maintain stability and coordination. The research also explores whether EVS-induced changes in vestibular function are linked to improvements in cognition and potential benefits for occasional headaches. The study involves 18 treatment sessions over 5 to 6 weeks where participants receive subthreshold wideband stochastic EVS through electrodes placed behind the ears and at the back of the neck. During each session, participants switch between sitting and standing on different surfaces with eyes open or closed while receiving stimulation. A sham comparator group receives no current during EVS treatment. Follow-up assessments occur at 3 weeks, 6 weeks, 3 months, and 6 months after treatment to evaluate lasting effects. Participants undergo various balance and gait tests using wearable sensors, smartphone app-based assessments, clinician-administered functional gait evaluations, and cognitive tests. Researchers measure outcomes such as postural sway, sensory integration, walking speed, step length, and trajectory before, during, and up to 6 months after treatment. Questionnaires assess headaches, cognition, dizziness, and physical activity. Safety and adverse events are monitored throughout the study.