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EEG Changes and DNA Markers Related to taVNS in Stroke Patients: a Preliminary Study

Study acronym: StrokeVNS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Enrollment target: 22 to 44v3 Show 7 more changesShow less
    • Primary completion date: Jan 31, 2025 to Jan 1, 2027
    • Primary endpoints: 2 to 3
    • Study completion date: Jun 30, 2025 to Jan 30, 2027
    • Study description expanded, about 95 words
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 3 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 22, 2024 to Jan 29, 2024
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06226493
Lead Sponsor Casa Colina Hospital and Centers for Healthcare
Collaborators: Foundation for Physical Medicine and Rehabilitation
Conditions
(from sponsor)
Stroke
Related terms Stroke
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov