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▎Stroke editors of WuXi AppTec's content team are a major health "killer" worldwide, and the number one cause of death and disability among Chinese adults.
According to data from the "China Stroke Report", more than 80% of stroke patients are deficient Bloody stroke (cerebral infarction).
Although the application of intravenous thrombolytic therapy and endovascular therapy (thrombectomy) has greatly improved the treatment of ischemic stroke, the burden of disability after stroke is extremely high.
About 80% of acute stroke patients will have upper limb motor dysfunction.
50%-60% of surviving patients continue to face this problem after 6 months, which seriously affects the quality of life of patients.
At present, there is almost no effective method to improve the recovery of upper limb function after stroke.
This highlights the need for complementary treatment strategies to better improve and promote patient recovery.
An important study published in the latest issue of The Lancet brings hope to this.
Studies have shown that through a neurostimulation therapy-vagus nerve stimulation, the upper limb function of patients with long-term disabilities after stroke can be significantly improved.
Screenshot source: The Lancet Vagus nerve stimulation is a therapy that has been used in diseases such as epilepsy and migraine.
In recent years, this therapy has also been explored in the field of ischemic stroke.
Through the regulation of motor cortex neurons, vagus nerve stimulation can promote brain remodeling, and by inhibiting neuroinflammation after stroke, it also helps to improve brain tissue recovery.
Previously, animal studies have shown that the combination of vagus nerve stimulation and rehabilitation exercise can help improve brain function and forelimb movement recovery in stroke rats.
Preliminary studies in 21 patients also support the effectiveness of this strategy.
Therefore, the University of Glasgow medical team led the study, hoping to verify the safety and effectiveness of vagus nerve stimulation for improving arm function after stroke in a larger study.
This is a pivotal, randomized, triple-blind, sham operation controlled trial conducted in 19 stroke rehabilitation services in the United Kingdom and the United States.
From October 2, 2017 to September 12, 2019, a total of 108 patients with moderate to severe arm weakness after 9 months of ischemic stroke were enrolled.
These patients were randomized 1:1 and received rehabilitation treatment combined with vagus nerve stimulation (VNS group, 53 people), or rehabilitation treatment combined with sham stimulation (control group, 55 people).
Depending on the degree of injury, patients need to receive 30-50 times × 6 groups of pulse stimulation per treatment, and each pulse stimulation lasts for 0.
5 seconds.
All patients were implanted with a vagus nerve stimulation device, and the patients, result assessors, and therapists were not aware of the actual treatment in the trial.
After 6 weeks of clinical treatment (3 times a week, 18 times in total), the subjects also received a home exercise program.
Image source: 123RF actually completed the study by 106 people (1 person in each group did not complete).
On the first day after the completion of clinical treatment, the arm function of the VNS group had a significantly better performance, the FMA-UE scale of the VNS group (a commonly used scale for evaluating motor function after stroke, the upper limb score range is 0-66 points) The score increased by an average of 5 points, while the control group increased by an average of 2.
4 points (the difference between groups was 2.
6 points, p = 0.
0014).
90 days after the clinical treatment, the advantage of the experimental treatment in improving arm function was still maintained.
47% (23 cases/53 cases) of the VNS group had clinically significant improvements in FMA-UE scores (increased by ≥6 points), while the proportion of the control group was only 24% (13 cases/55 cases).
The difference between the groups is significant.
In another functional assessment scale WMFT, the results are similar.
▲1 and 90 days after treatment, the scores of the two groups of patients on the FMA-UE scale (AC) and WMFT scale (DF) improved, and the proportion of patients whose improvement was clinically significant (picture source: reference [1]) trial The treatment group and the control group performed similarly in terms of safety.
At least one adverse event occurred in 81% and 76% of patients in the VNS group and the control group, respectively.
No patient died.
Two (4%) subjects in the VNS group had 3 serious adverse events (1 case each for urinary tract infection, hyponatremia and insomnia), and two (4%) subjects in the control group had 2 serious adverse events Event (headache and syncope, 1 case each).
The adverse events reported by 40% of the patients in the VNS group and 55% of the patients in the control group were assessed as possibly related to the implantation of therapeutic devices, and most of them were related to postoperative pain.
Adverse events reported by 25% and 16% of patients in the two groups were thought to be related to equipment use.
A serious adverse event (vocal cord paralysis) related to the implantation of the treatment device occurred in the control group, which resolved after 5 weeks.
There were no accidents or serious adverse events related to the test device.
Based on these data, the research team believes that the combination of vagus nerve stimulation and rehabilitation therapy has the potential to bring novel treatment options for patients with long-term, moderate and severe arm function impairment after ischemic stroke.
Image source: In a review article published by 123RF in the same period in The Lancet, Professors Anne van der Meij and Professor Marieke JH Wermer from the Department of Neurology of Leiden University in the Netherlands pointed out that in this trial, the patients had a stroke on average already Over 3 years, this suggests that vagus nerve stimulation is expected to bring benefits for a long time after a stroke.
The two experts are also full of expectations for the development of this technology.
"After successful treatment in the acute phase of stroke, this trial opened the door to treatment in the later phase of stroke.
With the emergence of neurostimulation therapy, including the trial of neurostimulation therapy published in The Lancet in 2019 to improve the acute treatment of cerebral infarction, an exciting potential new era of stroke treatment is beginning.
"Related reading "The Lancet": Just a touch of electricity! The new treatment for cerebral infarction improves the treatment rate, and how much pain will a stroke experience by extending the time window? After falling ill, Oxford experts found that they "know little" at birth.
Stroke, a 1/4 of the cerebral cortex is missing, but a normal life for 22 years.
.
.
The Lancet sub-Journal reported that the rare brain "remodeling" led by Professor Wang Yongjun to improve the function of stroke patients, the third phase of the Chinese neuroprotective innovative drug was published in the international journal "Lancet" Oxford large-scale study: Pay attention to the "atypical" symptoms of small strokes! The harm is similar, but often miss the diagnosis and treatment.
.
.
Reference [1] Jesse Dawson, et al.
, (2021).
Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)00475-X[2 ] Anne van der Meij, Marieke JH Wermer.
(2021).
Vagus nerve stimulation: a potential new treatment for ischaemic stroke.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)00667-X Note: This article is intended to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
According to data from the "China Stroke Report", more than 80% of stroke patients are deficient Bloody stroke (cerebral infarction).
Although the application of intravenous thrombolytic therapy and endovascular therapy (thrombectomy) has greatly improved the treatment of ischemic stroke, the burden of disability after stroke is extremely high.
About 80% of acute stroke patients will have upper limb motor dysfunction.
50%-60% of surviving patients continue to face this problem after 6 months, which seriously affects the quality of life of patients.
At present, there is almost no effective method to improve the recovery of upper limb function after stroke.
This highlights the need for complementary treatment strategies to better improve and promote patient recovery.
An important study published in the latest issue of The Lancet brings hope to this.
Studies have shown that through a neurostimulation therapy-vagus nerve stimulation, the upper limb function of patients with long-term disabilities after stroke can be significantly improved.
Screenshot source: The Lancet Vagus nerve stimulation is a therapy that has been used in diseases such as epilepsy and migraine.
In recent years, this therapy has also been explored in the field of ischemic stroke.
Through the regulation of motor cortex neurons, vagus nerve stimulation can promote brain remodeling, and by inhibiting neuroinflammation after stroke, it also helps to improve brain tissue recovery.
Previously, animal studies have shown that the combination of vagus nerve stimulation and rehabilitation exercise can help improve brain function and forelimb movement recovery in stroke rats.
Preliminary studies in 21 patients also support the effectiveness of this strategy.
Therefore, the University of Glasgow medical team led the study, hoping to verify the safety and effectiveness of vagus nerve stimulation for improving arm function after stroke in a larger study.
This is a pivotal, randomized, triple-blind, sham operation controlled trial conducted in 19 stroke rehabilitation services in the United Kingdom and the United States.
From October 2, 2017 to September 12, 2019, a total of 108 patients with moderate to severe arm weakness after 9 months of ischemic stroke were enrolled.
These patients were randomized 1:1 and received rehabilitation treatment combined with vagus nerve stimulation (VNS group, 53 people), or rehabilitation treatment combined with sham stimulation (control group, 55 people).
Depending on the degree of injury, patients need to receive 30-50 times × 6 groups of pulse stimulation per treatment, and each pulse stimulation lasts for 0.
5 seconds.
All patients were implanted with a vagus nerve stimulation device, and the patients, result assessors, and therapists were not aware of the actual treatment in the trial.
After 6 weeks of clinical treatment (3 times a week, 18 times in total), the subjects also received a home exercise program.
Image source: 123RF actually completed the study by 106 people (1 person in each group did not complete).
On the first day after the completion of clinical treatment, the arm function of the VNS group had a significantly better performance, the FMA-UE scale of the VNS group (a commonly used scale for evaluating motor function after stroke, the upper limb score range is 0-66 points) The score increased by an average of 5 points, while the control group increased by an average of 2.
4 points (the difference between groups was 2.
6 points, p = 0.
0014).
90 days after the clinical treatment, the advantage of the experimental treatment in improving arm function was still maintained.
47% (23 cases/53 cases) of the VNS group had clinically significant improvements in FMA-UE scores (increased by ≥6 points), while the proportion of the control group was only 24% (13 cases/55 cases).
The difference between the groups is significant.
In another functional assessment scale WMFT, the results are similar.
▲1 and 90 days after treatment, the scores of the two groups of patients on the FMA-UE scale (AC) and WMFT scale (DF) improved, and the proportion of patients whose improvement was clinically significant (picture source: reference [1]) trial The treatment group and the control group performed similarly in terms of safety.
At least one adverse event occurred in 81% and 76% of patients in the VNS group and the control group, respectively.
No patient died.
Two (4%) subjects in the VNS group had 3 serious adverse events (1 case each for urinary tract infection, hyponatremia and insomnia), and two (4%) subjects in the control group had 2 serious adverse events Event (headache and syncope, 1 case each).
The adverse events reported by 40% of the patients in the VNS group and 55% of the patients in the control group were assessed as possibly related to the implantation of therapeutic devices, and most of them were related to postoperative pain.
Adverse events reported by 25% and 16% of patients in the two groups were thought to be related to equipment use.
A serious adverse event (vocal cord paralysis) related to the implantation of the treatment device occurred in the control group, which resolved after 5 weeks.
There were no accidents or serious adverse events related to the test device.
Based on these data, the research team believes that the combination of vagus nerve stimulation and rehabilitation therapy has the potential to bring novel treatment options for patients with long-term, moderate and severe arm function impairment after ischemic stroke.
Image source: In a review article published by 123RF in the same period in The Lancet, Professors Anne van der Meij and Professor Marieke JH Wermer from the Department of Neurology of Leiden University in the Netherlands pointed out that in this trial, the patients had a stroke on average already Over 3 years, this suggests that vagus nerve stimulation is expected to bring benefits for a long time after a stroke.
The two experts are also full of expectations for the development of this technology.
"After successful treatment in the acute phase of stroke, this trial opened the door to treatment in the later phase of stroke.
With the emergence of neurostimulation therapy, including the trial of neurostimulation therapy published in The Lancet in 2019 to improve the acute treatment of cerebral infarction, an exciting potential new era of stroke treatment is beginning.
"Related reading "The Lancet": Just a touch of electricity! The new treatment for cerebral infarction improves the treatment rate, and how much pain will a stroke experience by extending the time window? After falling ill, Oxford experts found that they "know little" at birth.
Stroke, a 1/4 of the cerebral cortex is missing, but a normal life for 22 years.
.
.
The Lancet sub-Journal reported that the rare brain "remodeling" led by Professor Wang Yongjun to improve the function of stroke patients, the third phase of the Chinese neuroprotective innovative drug was published in the international journal "Lancet" Oxford large-scale study: Pay attention to the "atypical" symptoms of small strokes! The harm is similar, but often miss the diagnosis and treatment.
.
.
Reference [1] Jesse Dawson, et al.
, (2021).
Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)00475-X[2 ] Anne van der Meij, Marieke JH Wermer.
(2021).
Vagus nerve stimulation: a potential new treatment for ischaemic stroke.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)00667-X Note: This article is intended to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
