NCT06226493 EEG Changes and DNA Markers Related to taVNS in Stroke Patients: a Preliminary Study
| NCT ID | NCT06226493 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Casa Colina Hospital and Centers for Healthcare |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-01-29 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * First-time Cerebrovascular Accident (Ischemic or Hemorrhagic) * Within a month post-injury * Presence of motor impairments (FMA-U≤62) Exclusion Criteria: * 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 * Previous surgical intervention on the vagus nerve * Participation in other clinical trials * Alcohol or drug abuse
Contact & Investigator
Elliott Block, MD
PRINCIPAL INVESTIGATOR
Casa Colina Hospital and Centers for Healthcare
Frequently Asked Questions
Who can join the NCT06226493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226493 currently recruiting?
Yes, NCT06226493 is actively recruiting participants. Contact the research team at cschnakers@casacolina.org for enrollment information.
Where is the NCT06226493 trial being conducted?
This trial is being conducted at Pomona, United States.
Who is sponsoring the NCT06226493 clinical trial?
NCT06226493 is sponsored by Casa Colina Hospital and Centers for Healthcare. The principal investigator is Elliott Block, MD at Casa Colina Hospital and Centers for Healthcare. The trial plans to enroll 44 participants.
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