tVNS for Stroke Survivors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how transcutaneous vagus nerve stimulation (tVNS), a non-invasive therapy, affects pupil size in stroke survivors and healthy adults. It will compare the pupil response when stimulating one side of the ear versus both sides. Participants will receive both real and placebo treatments to determine any differences in pupil reactions. Individuals who have experienced a stroke and have weakness in one arm, but still retain some movement, might be eligible for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future therapies.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that transcutaneous vagus nerve stimulation (tVNS) is safe for stroke survivors?
Research has shown that transcutaneous vagus nerve stimulation (tVNS) is generally safe. Patients in studies have tolerated it well, with no reports of serious side effects. Any negative effects are typically mild and temporary. Specifically, for stroke patients, tVNS has helped improve arm movement. Overall, the treatment appears safe, with few safety concerns.12345
Why are researchers excited about this trial?
Researchers are excited about transcutaneous vagus nerve stimulation (tVNS) for stroke survivors because it offers a novel approach compared to standard treatments like physical therapy and medications that manage symptoms or prevent further strokes. Unlike these traditional methods, tVNS works by directly stimulating the vagus nerve through the skin of the outer ear, potentially enhancing brain recovery and neuroplasticity. This non-invasive technique could provide a new avenue for improving motor and cognitive functions in stroke patients, offering hope for enhanced recovery outcomes. The bilateral and unilateral applications of tVNS could also give insights into the most effective stimulation method, potentially leading to personalized treatment plans.
What evidence suggests that this trial's treatments could be effective for stroke survivors?
Research has shown that transcutaneous vagus nerve stimulation (tVNS) may aid stroke recovery. In animal studies, tVNS reduced the size of the damaged brain area during a stroke, potentially lessening brain damage. Another study found that combining tVNS with rehabilitation improved recovery of movement, senses, and emotions. In this trial, participants will receive different forms of tVNS—unilateral left, unilateral right, or bilateral—to assess its effectiveness. Beyond aiding stroke recovery, tVNS has also reduced symptoms of depression and anxiety, as reflected in improved mood test scores. Overall, tVNS appears to enhance recovery after a stroke by improving both physical and emotional functions.23678
Who Is on the Research Team?
Minoru Shinohara, Ph.D.
Principal Investigator
Georgia Institute of Technology
Are You a Good Fit for This Trial?
This trial is for stroke survivors and healthy adults interested in how a non-invasive nerve stimulation technique affects pupil size. Participants must be eligible based on specific criteria set by the study, which are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive unilateral and bilateral tVNS and sham stimulation to assess acute pupil response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- tVNS
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgia Institute of Technology
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Emory University
Collaborator