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EEG Changes and DNA Markers Related to taVNS in Stroke Patients: a Preliminary Study
Sponsor: Casa Colina Hospital and Centers for Healthcare
Summary
In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) and genetic markers related to improvements in both motor and cognitive recovery following the use of taVNS vs. sham in acute stroke patients.
Official title: EEG Changes and DNA Markers Related to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Acute Stroke Patients: a Preliminary Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-01-29
Completion Date
2027-01-30
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous vagus nerve stimulation
The Parasym Plus device (https://parasym.io) is a transcutaneous auricular vagus nerve stimulator that has been deemed non-significant risk (NSR) by the FDA. Transcutaneous auricular vagus nerve stimulator is a non-significant risk device, as it involves electrical stimulation of the external ear using an ear clip, with no invasive components. The stimulation parameters will be limited to the confines of existing published data. tVNS is safe and well tolerated at doses tested in research studies. The Parasym device is considered low risk when used in accordance with the instructions for use. Participants will be properly trained to use the device, and those with contraindications will be excluded for extra precaution. A low incidence of skin irritation has been reported. No serious adverse events have been reported.
Locations (1)
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States