Vagus nerve stimulation as a promising adjunctive treatment for ischemic stroke

Background. Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective. To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods. All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment—Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results. There were no VNS treatment–related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year. Conclusions. VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.

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NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial

Trials ◽

10.1186/s13063-020-04794-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Anne van der Meij ◽

Marianne A. A. van Walderveen ◽

Nyika D. Kruyt ◽

Erik W. van Zwet ◽

Eric J. Liebler ◽

...

Keyword(s):

Clinical Trial ◽

Ischemic Stroke ◽

Vagus Nerve ◽

Randomized Clinical Trial ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Standard Treatment ◽

Infarct Volume ◽

Non Invasive ◽

Link Type

Abstract Background Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume. Methods NOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI. Discussion We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke. Trial registration ClinicalTrials.govNCT04050501. Registered on 8 August 2019

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Neuromodulation Therapy with Vagus Nerve Stimulation for Intractable Epilepsy: A 2-Year Efficacy Analysis Study in Patients under 12 Years of Age

Epilepsy Research and Treatment ◽

10.1155/2016/9709056 ◽

2016 ◽

Vol 2016 ◽

pp. 1-5 ◽

Cited By ~ 8

Author(s):

Suresh Gurbani ◽

Sirichai Chayasirisobhon ◽

Leslie Cahan ◽

SooHo Choi ◽

Bruce Enos ◽

...

Keyword(s):

Vagus Nerve ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Focal Epilepsy ◽

Intractable Epilepsy ◽

Cumulative Effect ◽

Adjunctive Treatment ◽

Seizure Freedom ◽

Primary Generalized Epilepsy ◽

Generalized Epilepsy

To study the efficacy of vagus nerve stimulation (VNS) therapy as an adjunctive treatment for intractable epilepsy in patients under 12 years of age, we analyzed 2-year postimplant data of 35 consecutive patients. Of the 35 patients, 18 (51.4%) at 6 months, 18 (51.4%) at 12 months, and 21 (60.1%) at 24 months showed ≥50% reduction in seizure frequency (responders). Although incremental seizure freedom was noted, no patient remained seizure-free throughout the 3 study periods. Partial response (≥50% seizure reduction in 2 or less study periods) was seen in 8 (22.9%) patients. Twelve patients (34.3%) were nonresponders. Out of 29 patients with primary generalized epilepsy, 20 (68.9%) and, out of 6 patients with focal epilepsy, 3 (50%) had ≥50% seizure control in at least one study period. No major complications or side effects requiring discontinuation of VNS therapy were encountered. We conclude that (1) patients with intractable primary generalized epilepsy respond better to VNS therapy, (2) cumulative effect of neuromodulation with improving responder rate to seizure freedom with continuation of VNS therapy is noted, and (3) VNS therapy is safe and is well tolerated in children receiving implant under 12 years of age.

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Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke

Case Medical Research ◽

10.31525/ct1-nct04050501 ◽

2019 ◽

Author(s):

Keyword(s):

Ischemic Stroke ◽

Vagus Nerve ◽

Acute Ischemic Stroke ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Non Invasive

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Non-invasive vagus nerve stimulation reduces blood-brain barrier disruption in a rat model of ischemic stroke

Brain Stimulation ◽

10.1016/j.brs.2018.01.034 ◽

2018 ◽

Vol 11 (4) ◽

pp. 689-698 ◽

Cited By ~ 16

Author(s):

Yirong Yang ◽

Lisa Y. Yang ◽

Lilla Orban ◽

Darnell Cuylear ◽

Jeffrey Thompson ◽

...

Keyword(s):

Ischemic Stroke ◽

Vagus Nerve ◽

Blood Brain Barrier ◽

Rat Model ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Barrier Disruption ◽

Non Invasive ◽

Blood Brain Barrier Disruption ◽

Brain Barrier Disruption

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Efficacy of vagus nerve stimulation in posttraumatic versus nontraumatic epilepsy

Journal of Neurosurgery ◽

10.3171/2012.8.jns122 ◽

2012 ◽

Vol 117 (5) ◽

pp. 970-977 ◽

Cited By ~ 28

Author(s):

Dario J. Englot ◽

John D. Rolston ◽

Doris D. Wang ◽

Kevin H. Hassnain ◽

Charles M. Gordon ◽

...

Keyword(s):

Vagus Nerve ◽

Seizure Frequency ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Prospective Trial ◽

Treatment Strategies ◽

Adjunctive Treatment ◽

Posttraumatic Epilepsy ◽

Improved Outcomes ◽

Antiepileptic Medications

Object In the US, approximately 500,000 individuals are hospitalized yearly for traumatic brain injury (TBI), and posttraumatic epilepsy (PTE) is a common sequela of TBI. Improved treatment strategies for PTE are critically needed, as patients with the disorder are often resistant to antiepileptic medications and are poor candidates for definitive resection. Vagus nerve stimulation (VNS) is an adjunctive treatment for medically refractory epilepsy that results in a ≥ 50% reduction in seizure frequency in approximately 50% of patients after 1 year of therapy. The role of VNS in PTE has been poorly studied. The aim of this study was to determine whether patients with PTE attain more favorable seizure outcomes than individuals with nontraumatic epilepsy etiologies. Methods Using a case-control study design, the authors retrospectively compared seizure outcomes after VNS therapy in patients with PTE versus those with nontraumatic epilepsy (non-PTE) who were part of a large prospectively collected patient registry. Results After VNS therapy, patients with PTE demonstrated a greater reduction in seizure frequency (50% fewer seizures at the 3-month follow-up; 73% fewer seizures at 24 months) than patients with non-PTE (46% fewer seizures at 3 months; 57% fewer seizures at 24 months). Overall, patients with PTE had a 78% rate of clinical response to VNS therapy at 24 months (that is, ≥ 50% reduction in seizure frequency) as compared with a 61% response rate among patients with non-PTE (OR 1.32, 95% CI 1.07–1.61), leading to improved outcomes according to the Engel classification (p < 0.0001, Cochran-Mantel-Haenszel statistic). Conclusions Vagus nerve stimulation should be considered in patients with medically refractory PTE who are not good candidates for resection. A controlled prospective trial is necessary to further examine seizure outcomes as well as neuropsychological outcomes after VNS therapy in patients with intractable PTE.

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