No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
Casa Colina Hospital and Centers for Healthcare · Other
Who this trial is looking for
This trial is looking for people who have had a stroke within the last month and have motor impairments. Participants will receive either active treatment or a placebo while we measure changes in brain activity and recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke for the first time.
It has been less than a month since my stroke.
I have motor impairments.
You may not be able to join if
I have advanced heart disease.
I have advanced lung disease.
I have advanced liver disease.
I have advanced kidney disease.
My resting heart rate is below 60 beats per minute.
I have confusion or speech difficulties.
I have other serious neurological problems.
I have had surgery on my vagus nerve.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 str…
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 Locations
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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 o…
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
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