In what multiverse do you live if you think this will get to your hospital if all these earlier ones didn't make it? And still no protocol created.
vagus nerve (56 posts to July 2012)
Paired vagus nerve stimulation for treatment of upper extremity impairment after stroke
Jesse Dawsonhttps://orcid.org/0000-0001-7532-24751 and Azmil H Abdul-Rahim2
Abstract
The use of a paired vagus nerve stimulation (VNS) system for the treatment of moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke has recently been approved by the US Food and Drug Administration. This treatment aims to increase the task-specific neuroplasticity through the activation of cholinergic and noradrenergic networks during rehabilitation therapy. A recent pivotal Phase III trial showed that VNS paired with rehabilitation led to improvements in upper extremity impairment and function in people with moderate-to-severe arm weakness for an average of 3 years after ischemic stroke. The between-group difference following 6 weeks of in-clinic therapy and 90 days of home exercise therapy was three points on the upper extremity Fugl-Meyer score. A clinically meaningful response defined as a greater than or equal to six-point improvement was seen in approximately half of the people treated with VNS compared to approximately a quarter of people treated with rehabilitation alone. Further post-marketing research should aim to establish whether the treatment is also of use for people with intracerebral hemorrhage, in people with more severe arm weakness, and for other post-stroke impairments. In addition, high-quality randomized studies of non-invasive VNS are required.
Keywords
Stroke, rehabilitation, upper limb
1Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
2Institute of Neuroscience and Psychology, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
Corresponding author(s):
Jesse Dawson, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, QEUH, Glasgow G12 9QQ, UK. Email: jesse.dawson@glasgow.ac.uk
Introduction
The use of a paired vagus nerve stimulation (VNS) system for the treatment of moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke has recently been approved by the US Food and Drug Administration (FDA).1 This is a potentially important advance for many stroke survivors. Upper extremity impairment is one of the commonest stroke symptoms, occurring in approximately 75% of people with stroke2 and while many exhibit substantial spontaneous recovery, long-term problems persist in approximately half.3 This has a considerable impact on quality of life and therefore, improving upper extremity impairment is a priority for stroke survivors.4
In recent years, several advances have been made in methods used to predict recovery5 and in our understanding of the benefits and limitations of current rehabilitation techniques.6 High-intensity rehabilitation therapy may improve upper extremity outcomes but may be challenging to deliver at scale.7,8 However, numerous new approaches to rehabilitation are being studied and incorporated into clinical practice.
Many of these novel approaches attempt to target the pathophysiology that underpins motor weakness after stroke and the processes of recovery. These processes are likely to differ with stroke subtypes and with time after stroke. For example, interventions that are effective in the chronic phase of stroke recovery may not be effective in the acute or subacute phase, and the mechanism of tissue damage and repair differs in ischemic and hemorrhagic stroke. Following an ischemic stroke, there is cell death in the affected area, leading to the loss of brain tissue and atrophy. However, there are also changes both proximal and distal to the lesion and in connected areas. For example, secondary axonal degeneration occurs in white matter tracts and loss of gray matter volume can occur both ipsilateral and contralateral to the stroke lesion.9 The extent and type of this damage is related to stroke severity and may explain some of the variance in outcomes following rehabilitation. The ability of the brain to reorganize neural networks after the stroke injury is critical but is often insufficient to lead to meaningful recovery. These plastic changes involve both peri-lesional tissue and the contralateral hemisphere, subcortical, and spinal regions. Studies have reported a role for the cholinergic,10,11 noradrenergic, and serotonergic systems in remapping after stroke. Thus, outcomes after stroke could be improved by both reducing initial stroke severity through reperfusion and some of the mechanisms of secondary injury, and by improving the ability of the brain to reorganize. The extent of reorganization of neural networks can be enhanced by rehabilitation and task-specific training. In experimental models, task-specific rehabilitation has been shown to increase “cortical re-wiring,” increase synaptogenesis, and increase dendritic cell branching and growth.12 This plasticity can be specific to the applied stimulus and augmenting task-specific plasticity is a key therapeutic target.
Abstract
The use of a paired vagus nerve stimulation (VNS) system for the treatment of moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke has recently been approved by the US Food and Drug Administration. This treatment aims to increase the task-specific neuroplasticity through the activation of cholinergic and noradrenergic networks during rehabilitation therapy. A recent pivotal Phase III trial showed that VNS paired with rehabilitation led to improvements in upper extremity impairment and function in people with moderate-to-severe arm weakness for an average of 3 years after ischemic stroke. The between-group difference following 6 weeks of in-clinic therapy and 90 days of home exercise therapy was three points on the upper extremity Fugl-Meyer score. A clinically meaningful response defined as a greater than or equal to six-point improvement was seen in approximately half of the people treated with VNS compared to approximately a quarter of people treated with rehabilitation alone. Further post-marketing research should aim to establish whether the treatment is also of use for people with intracerebral hemorrhage, in people with more severe arm weakness, and for other post-stroke impairments. In addition, high-quality randomized studies of non-invasive VNS are required.
Keywords
Stroke, rehabilitation, upper limb
1Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
2Institute of Neuroscience and Psychology, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
Corresponding author(s):
Jesse Dawson, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, QEUH, Glasgow G12 9QQ, UK. Email: jesse.dawson@glasgow.ac.uk
Introduction
The use of a paired vagus nerve stimulation (VNS) system for the treatment of moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke has recently been approved by the US Food and Drug Administration (FDA).1 This is a potentially important advance for many stroke survivors. Upper extremity impairment is one of the commonest stroke symptoms, occurring in approximately 75% of people with stroke2 and while many exhibit substantial spontaneous recovery, long-term problems persist in approximately half.3 This has a considerable impact on quality of life and therefore, improving upper extremity impairment is a priority for stroke survivors.4
In recent years, several advances have been made in methods used to predict recovery5 and in our understanding of the benefits and limitations of current rehabilitation techniques.6 High-intensity rehabilitation therapy may improve upper extremity outcomes but may be challenging to deliver at scale.7,8 However, numerous new approaches to rehabilitation are being studied and incorporated into clinical practice.
Many of these novel approaches attempt to target the pathophysiology that underpins motor weakness after stroke and the processes of recovery. These processes are likely to differ with stroke subtypes and with time after stroke. For example, interventions that are effective in the chronic phase of stroke recovery may not be effective in the acute or subacute phase, and the mechanism of tissue damage and repair differs in ischemic and hemorrhagic stroke. Following an ischemic stroke, there is cell death in the affected area, leading to the loss of brain tissue and atrophy. However, there are also changes both proximal and distal to the lesion and in connected areas. For example, secondary axonal degeneration occurs in white matter tracts and loss of gray matter volume can occur both ipsilateral and contralateral to the stroke lesion.9 The extent and type of this damage is related to stroke severity and may explain some of the variance in outcomes following rehabilitation. The ability of the brain to reorganize neural networks after the stroke injury is critical but is often insufficient to lead to meaningful recovery. These plastic changes involve both peri-lesional tissue and the contralateral hemisphere, subcortical, and spinal regions. Studies have reported a role for the cholinergic,10,11 noradrenergic, and serotonergic systems in remapping after stroke. Thus, outcomes after stroke could be improved by both reducing initial stroke severity through reperfusion and some of the mechanisms of secondary injury, and by improving the ability of the brain to reorganize. The extent of reorganization of neural networks can be enhanced by rehabilitation and task-specific training. In experimental models, task-specific rehabilitation has been shown to increase “cortical re-wiring,” increase synaptogenesis, and increase dendritic cell branching and growth.12 This plasticity can be specific to the applied stimulus and augmenting task-specific plasticity is a key therapeutic target.
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