Vagal Nerve Stimulation for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device that clips onto the ear to determine its effectiveness in improving sleep for people recovering from a stroke. Researchers aim to discover whether this device, which provides transauricular Vagal Nerve Stimulation, aids with insomnia and impacts stroke recovery, such as mobility or cognitive skills. Participants will use the device for 30 minutes each evening for at least 10 days. The trial seeks individuals who have experienced an ischemic stroke, are currently in a rehabilitation hospital, and have difficulty sleeping. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stroke recovery and improve sleep.
What prior data suggests that this device is safe for individuals recovering from stroke?
Research has shown that vagal nerve stimulation (VNS) is generally safe and well-tolerated. Studies indicate that when used properly, complications are rare, and most side effects are mild. For example, some people might feel tingling or experience skin irritation where the device is placed. This is reassuring, especially since the device used in this trial is non-invasive and applied only to the ear.
Although specific data on using ear-based VNS for stroke recovery is limited, existing evidence suggests that VNS is safe for humans. This trial aims to explore how VNS might improve sleep during stroke recovery, so any new findings will enhance current knowledge about the device's safety.12345Why are researchers excited about this trial?
Unlike traditional stroke rehabilitation treatments that focus on physical therapy and medications, transauricular Vagal Nerve Stimulation (taVNS) is unique because it uses a non-invasive device to stimulate the vagus nerve through the ear. This method potentially enhances cognitive function and improves sleep quality, which are critical aspects of stroke recovery. Researchers are excited about this approach as it offers a novel mechanism of action, tapping into the body's natural communication pathways to promote healing and recovery, possibly offering quicker and more integrated improvements than conventional therapies.
What evidence suggests that this device is effective for improving sleep in stroke patients?
Research has shown that stimulating the vagus nerve through the ear (taVNS) can aid stroke recovery. In this trial, participants will receive either transauricular Vagal Nerve Stimulation (taVNS) or a Sham taVNS as part of their rehabilitation. Studies have found that combining taVNS with rehabilitation exercises leads to better recovery than rehabilitation alone. For example, some studies observed improved arm strength and movement in stroke patients using taVNS. Additionally, research on animals suggested that taVNS might reduce brain damage after a stroke. Overall, these findings indicate that taVNS could support stroke recovery, including enhancing sleep and mental function.678910
Who Is on the Research Team?
Emily Rosario, PhD
Principal Investigator
Casa Colina Hospital and Centers for Healthcare
Are You a Good Fit for This Trial?
This trial is for people recovering from a recent stroke who are staying in a rehabilitation hospital. Participants should have trouble sleeping (insomnia) and be able to use an ear-clip device each evening during their stay.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the taVNS device for 30 minutes daily between 7-9pm for at least 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including reassessment of the Insomnia Severity Index
What Are the Treatments Tested in This Trial?
Interventions
- transauricular Vagal Nerve Stimulation
Trial Overview
The study tests whether gentle electrical stimulation of the vagus nerve through an ear clip can improve sleep after stroke. Participants will either get real stimulation or use a similar device that does not deliver any stimulation (sham).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. These participants will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions.
Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. For this group, their issued devices will include a sham earpiece that will prevent transmission of taVNS. The ISI will be re-assessed at 12-15 days, or earlier if the patient discharges prior to this timeline. Participants will continue to receive the usual care for their individual rehabilitation program, including therapy and medications.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Casa Colina Hospital and Centers for Healthcare
Lead Sponsor
Citations
1.
amerihealthcaritasnh.com
amerihealthcaritasnh.com/content/dam/amerihealth-caritas/acnh/pdf/provider/resources/clinical/20261022/ccp1515-vns-post-stroke-rehab.pdf.coredownload.inline.pdfVagus nerve stimulation for post-stroke upper limb ...
Effectiveness of transcutaneous auricular vagus nerve stimulation in stroke rehabilitation: a systematic review and meta-analysis of randomized clinical trials.
Vagus Nerve Stimulation, Rehab Effective After Stroke
Vagus nerve stimulation combined with rehabilitation exceeds rehabilitation alone for poststroke arm weakness, new research suggests.
Effectiveness of transcutaneous auricular vagus nerve ...
A Correction on Effectiveness of transcutaneous auricular vagus nerve stimulation in stroke rehabilitation: a systematic review and meta-analysis of ...
tVNS for Stroke Survivors · Info for Participants
Research has shown that transcutaneous vagus nerve stimulation (tVNS) may aid stroke recovery. In animal studies, tVNS reduced the size of the damaged brain ...
5.
amerihealthcaritasvipcare.com
amerihealthcaritasvipcare.com/content/dam/amerihealth-caritas/vip-care/pdf/de/provider/resources/clinical/policies-20260722/ccp1515-Vagus%20nerve%20stimulation%20for%20post-stroke%20upper%20limb%20rehabilitation.pdf.coredownload.inline.pdfVagus nerve stimulation for post-stroke upper limb ...
Effectiveness of transcutaneous auricular vagus nerve stimulation in stroke rehabilitation: a systematic review and meta-analysis of randomized clinical trials.
The vagal innervation of the gut and immune homeostasis
Indeed, VN electrical stimulation potently reduces intestinal inflammation restoring intestinal homeostasis, whereas vagotomy has the reverse effect. In this ...
Achala Vagal, MD| Profile | UC College of Medicine
Achala Vagal is a nationally recognized physician-scientist whose research lies at the intersection of stroke imaging, imaging biomarkers, population brain ...
5 Ways to Stimulate and Regulate Your Vagus Nerve
What most people do not realize about the vagus nerve is that you can train it like a muscle. Vagal tone is not fixed. It is adaptable.
A neuroanatomical basis for electroacupuncture to drive ...
Low-intensity ES at the ST36 site in mice with ablated PROKR2Cre-marked sensory neurons failed to activate hindbrain vagal efferent neurons or ...
Electrical Grounding Improves Vagal Tone in Preterm Infants
Background: Low vagal tone (VT) is a marker of vulnerability to stress and the risk of developing necrotizing enterocolitis in preterm infants.
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