52 Participants NeededMy employer runs this trial

Vagal Nerve Stimulation for Stroke

MY
HC
Overseen ByHannah Cone, PT, DPT, NCS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Casa Colina Hospital and Centers for Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

ER

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

Admitted to Casa Colina's acute rehabilitation service
I have been diagnosed with an ischemic stroke.
English or Spanish speaking
See 3 more

Exclusion Criteria

I have another diagnosed neurological condition.
Permanent implanted metallic or electronic device or jewelry within 2cm of the ear tragus
Pregnancy
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-5 days
1 visit (in-person)

Treatment

Participants use the taVNS device for 30 minutes daily between 7-9pm for at least 10 days

10-15 days
Daily use (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including reassessment of the Insomnia Severity Index

2 weeks
Reassessment at discharge

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

Group I: transauricular Vagal Nerve Stimulation (taVNS)Experimental Treatment1 Intervention
Group II: Sham transauricular Vagal Nerve Stimulation (Sham taVNS)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Casa Colina Hospital and Centers for Healthcare

Lead Sponsor

Trials
11
Recruited
350+

Citations

Vagus 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 ...

Vagus 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.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23023166/

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 ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28601861/

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.