About this trial
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.
Eligibility criteria
Qualifiers
First-time Cerebrovascular Accident (Ischemic or Hemorrhagic)
Within a month post-injury
Presence of motor impairments (FMA-U≤62)
Disqualifiers
Advanced cardiac, pulmonary, liver, or kidney disease
Bradycardia (Resting HR < 60)
Presence of Apraxia, Aphasia or confusion
Other musculoskeletal or neurologic diseases that could interfere with the outcome measures
Trial design
Treatments tested in this trial
- Transcutaneous vagus nerve stimulation
Treatment groups
Sponsors and collaborators
Casa Colina Hospital and Centers for Healthcare
Lead sponsor
Foundation for Physical Medicine and Rehabilitation
Collaborator