Cupertino

Researchers are evaluating the use of the HeadPulse device to observe data in individuals, including children as young as 4 years old, who have experienced a concussion or mild traumatic brain injury mTBI. This observational study focuses on sports teams where the risk of concussion is higher and aims to confirm previous findings from professional athletes. The goal is to validate the HeadPulse as a digital biometric tool that can objectively indicate ongoing brain concussion even when a person feels no symptoms, supporting safer decisions for returning to play or normal activities. Participants include those diagnosed or suspected of having a concussion or mTBI and those without such diagnosis in the previous year. The study compares data from these groups to better understand concussion recovery. Data collection will occur over approximately 30 days after enrollment, focusing on HeadPulse abnormalities and monitoring if subjects worsen after being cleared to resume activities. Participants will be observed with HeadPulse measurements and evaluations during the study period. Researchers will monitor the time course of biometric abnormalities and the proportion of subjects who experience worsening symptoms after being cleared for activity. The study involves no treatment intervention but collects data to support device development. Participation may last around 30 days from enrollment, with ongoing safety and recovery assessments throughout this time.

This research aims to evaluate the safety, feasibility, effectiveness, and lasting impact of non-invasive electrical vestibular stimulation EVS on balance and walking ability in healthy adults aged 18 to 100 years. It focuses on how EVS influences balance and gait by measuring performance before, during, and after single and repeated sessions at multiple partner sites. The study addresses age-related balance decline, known as presbystasis, which increases fall risk and affects independence, especially in older adults, and explores EVS as a potential non-invasive solution to restore vestibular function and possibly improve cognitive function and headaches. Participants will receive either active treatment with sub-threshold wideband stochastic EVS swsEVS or a sham treatment with no stimulation, in a randomized, single-blind design. The study involves 18 testing sessions over 5 to 6 weeks, where participants undergo EVS while alternating sitting and standing positions with eyes open or closed. Several assessments will be conducted including accelerometer-based gait and balance tests using a smartphone app, clinician-administered Functional Gait Assessments, static and dynamic balance tests, cognitive tests, and questionnaires about headaches and dizziness. Participants will complete balance and gait tests before and after each EVS session, with follow-up visits at 3 weeks, 6 weeks, 3 months, and 6 months post-treatment to evaluate lasting effects. Cognitive assessments and headache questionnaires are done during the first and last treatment sessions. Safety and tolerability are monitored throughout. The main outcomes measured include various balance and gait parameters such as postural sway, gait velocity, cadence, step length, and step trajectory, along with cognitive performance tests, to assess the impact of the stimulation over time.