Vagus Nerve Stimulation for Stroke Rehabilitation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how Vagus Nerve Stimulation (VNS) therapy can improve leg function after a stroke. Participants will receive either active VNS therapy or a placebo treatment during rehabilitation. It is ideal for individuals who have experienced a stroke, have some movement in their affected hand, and face challenges with walking but can walk short distances independently. The goal is to determine if VNS can significantly aid in recovering mobility. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery treatments.
What prior data suggests that Vagus Nerve Stimulation therapy is safe for stroke rehabilitation?
Research has shown that Vagus Nerve Stimulation (VNS) therapy is generally well-tolerated. In various studies, patients receiving VNS demonstrated noticeable improvements in movement, particularly after a stroke. These studies also confirm that VNS is safe and practical for rehabilitation.
Safety checks from clinical trials consistently indicate that VNS does not cause significant side effects. While minor side effects may occur, they are neither serious nor common enough to raise concern. Overall, VNS therapy appears to be a safe option for those considering participation in a clinical trial.12345Why are researchers excited about this trial?
Vagus Nerve Stimulation (VNS) Therapy for stroke rehabilitation is unique because it uses electrical impulses to stimulate the vagus nerve, which is thought to help the brain reorganize and recover function after a stroke. Unlike traditional rehabilitation methods that mainly focus on physical exercises and therapy, VNS targets the nervous system directly, potentially enhancing recovery by promoting neuroplasticity—the brain's ability to form new connections. Researchers are excited about this treatment because it could lead to faster and more effective recovery for stroke patients, offering a new hope for regaining lost abilities.
What evidence suggests that Vagus Nerve Stimulation is effective for stroke rehabilitation?
Research has shown that Vagus Nerve Stimulation (VNS) therapy can improve movement after a stroke. In this trial, participants will divide into two groups: one receiving active VNS stimulation during therapy (VNS ON) and the other receiving no stimulation (VNS OFF). Studies have found that people who received VNS therapy experienced noticeable improvements in arm and hand strength and movement. These improvements lasted for up to a year, enhancing their daily lives. Other research suggests that combining VNS therapy with rehabilitation exercises can lead to significant recovery in movement abilities. While most studies have focused on arms and hands, these results indicate that VNS might also aid in leg rehabilitation.14567
Who Is on the Research Team?
Assaf Berger, MD
Principal Investigator
University at Buffalo
Are You a Good Fit for This Trial?
This trial is for adults who have had a stroke and are experiencing weakness in their arm or leg. Participants should be able to take part in rehabilitation therapy. People with certain medical conditions or other factors that could interfere with the study may not be eligible.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Vagus nerve electrodes and chest generator are permanently implanted prior to the beginning of rehabilitation
Treatment
Participants undergo 4.5 months of in-clinic and home therapy with VNS ON or OFF for lower limb and gait rehabilitation
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments conducted up to 90 days post-operation
What Are the Treatments Tested in This Trial?
Interventions
- Vagus Nerve Stimulation Therapy
Trial Overview
The study is testing whether Vagus Nerve Stimulation (VNS) therapy, combined with standard rehabilitation, can improve walking ability after a stroke. Participants are randomly assigned to receive either VNS or a placebo treatment along with rehab.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Receives active stimulation during therapy
No stimulation during therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
Citations
Long-Term Outcomes of Vagus Nerve Stimulation Paired ...
People treated with paired vagus nerve stimulation maintained improvements in UE impairment, activity, participation, and quality-of-life measures at 1 year.
The Effect of Vagus Nerve Stimulation on the Rehabilitation ...
The results showed that patients receiving VNS had significant improvements in Fugl-Meyer Assessment Upper Extremity (FMA-UE) D-VNS and ta-VNS ...
Adjuvant effects of vagus nerve stimulation on post-stroke ...
Studies were required to report efficacy outcomes (such as upper extremity motor function and swallowing function) as well as safety outcomes.
Effects and safety of vagus nerve stimulation on upper limb ...
The results showed that VNS improves outcomes such as level of motor impairment and motor function. In addition, there was no significant ...
Vagus Nerve Stimulation Paired With Upper Extremity ...
By 6 months poststroke, two-thirds of individuals have not regained sufficient upper extremity function . For simple 1-step tasks, stimulation ...
Vagus nerve stimulation paired with rehabilitation for stroke
This study is the largest, randomized, controlled trial in which a VNS device was implanted in chronic stroke survivors.
Vagus Nerve Stimulation Paired With Upper Limb ...
VNS paired with rehabilitation was acceptably safe and feasible in participants with upper limb motor deficit after chronic ischemic stroke.
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