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At present, about 1.
8 million adults worldwide suffer from severe bilateral vestibular dysfunction, which is mainly manifested as chronic balance disorder, vibration hallucinations, gait instability and even falls, which seriously affect the lives and physical and mental health of patients.
The traditional treatment of the disease mainly uses vestibular rehabilitation exercises and vestibular stimulation treatments (sound, vibration, electrical stimulation, etc.
), but these treatments are not helpful for gait improvement.
The New England Journal of Medicine published on February 11, 2021, the Johns Hopkins University School of Medicine team on the clinical effect of artificial vestibular implantation in 8 patients with bilateral vestibular dysfunction.
This study is the first to show in daily life that artificial implantation devices have significantly improved the patient's balance, gait stability and quality of life through long-term follow-up, marking an important new development in the field of vestibular medicine.
We invited Professor Wu Hao, chairman of the Otorhinolaryngology Head and Neck Surgery Branch of the Chinese Medical Association and dean of the Ninth People’s Hospital of Shanghai Jiaotong University School of Medicine, to interpret this paper.
To read the full text translation, please visit NEJM Medical Frontier's official website, APP or click on the picture of the WeChat applet.
Wu Hao, Department of Otorhinolaryngology, Head and Neck Surgery, the Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, led by Professor Della Santina’s team in Otorhinolaryngology Head and Neck Surgery, Johns Hopkins University School of Medicine, used artificial labor developed by Labyrinth Devices and Med-El.
The vestibular implant device is implanted into the patient's inner ear to perform chronic electrical stimulation on the vestibular nerve branches in the three semicircular canals.
After 1 year of follow-up, the author reported that unilateral vestibular implantation can improve the posture, gait and quality of life of patients with bilateral vestibular dysfunction, and achieved satisfactory results.
Although 7 out of 8 implanters had hearing loss on the implant side, this technology still provides a new treatment for bilateral vestibular dysfunction.
What is artificial vestibular implantation.
The vestibule is the most important balance receptor in the human body, which combines visual and proprioceptive systems to maintain body posture.
The vestibule is located in the inner ear and includes three semicircular canals, an utricle and a balloon.
The semicircular canals sense the angular acceleration of the body's rotation, and the utricle and balloon sense the linear acceleration of the body.
Impairment of vestibular function will affect the body's balance function, posture control, etc.
, resulting in corresponding clinical symptoms.
Since it is found that electrical stimulation of the vestibular ampulla nerve can induce eye movements, in theory, artificial electrical signal stimulation of the corresponding structure may replace the body's sensory function and restore or partially restore the vestibular function.
At present, this kind of functional replacement mainly adopts three methods: cochlear implantation to co-stimulate the vestibule, artificial vestibular implantation to stimulate the vestibule, and non-implantable electrical stimulation.
Figure 1.
The components and mechanism of the vestibular implant device.
This article uses an artificial vestibular implant to electrically stimulate the vestibule.
The device is modified on the basis of a cochlear implant and adds an electrode array to achieve electrical stimulation of three semicircular canals.
, Can continue to give bidirectional current pulses, the rate and amplitude of the current pulses depend on the head rotation speed and axis direction.
The device includes: an external head-mounted unit for sensing head rotation (three components, each component corresponding to a semicircular canal), and transmitting a signal to the internal processor through the coil percutaneously; internal implanting unit, including implant The electrodes into the semicircular canal, as well as the power supply and micro-processing control unit that contain the battery and store the stimulation settings and control the pulses.
Compared with cochlear implantation, artificial vestibular implantation surgery is slightly more difficult.
At present, there are mainly two types of labyrinth inner approach and labyrinth outer approach.
The inner labyrinth approach requires opening the bony labyrinth and implanting electrodes into the perilymph space/ampullary of the semicircular canal; the outer labyrinth approach places the electrodes on the vestibular nerve outside the labyrinth or even directly on the Scarpa ganglion.
Both methods can achieve electrical evoked vestibular response, but the labyrinthine approach has a higher risk of residual hearing loss.
Although most vestibular implant subjects have severe hearing loss, for people with bilateral vestibular disease, hearing protection still needs additional attention.
Although there is a certain risk of sensory nerve and conductive hearing loss as well as facial nerve damage to the labyrinthic outer path, the electrode is placed closer to the target point and the effective stimulation current may be smaller.
In this paper, the labyrinthine internal approach is adopted.
A small hole with a diameter of about 0.
6 mm is made at the ampulla of each semicircular canal.
The electrode array is implanted and sealed with fascia and bone meal.
The reference electrode is placed on the total leg of the labyrinthine semicircular canal or implanted body capsule.
At the bag.
The clinical research on artificial vestibular implantation has been reported since 2007, but most of them were performed with acute or intermittent electrical stimulation.
Only the team in this article implemented chronic electrical stimulation and conducted a 1-year period of electrical stimulation.
Follow-up, and the patient used it both at the research center and at home.
Because only in this case, can the use analysis in the real daily environment be carried out.
This is also the characteristic of this research.
Study Design This study is a prospective, single-center, non-randomized, single-group, self-controlled study.
After recruiting patients with indications and eliminating contraindications, collect the patient's related posture and gait, dizziness and exercise ability, quality of life, and hearing conditions within a week before surgery, and perform it again at 3 weeks, 6 months, and 1 year after implantation Evaluation.
After implantation, the device operates for 24 hours and continuously stimulates the 3 semicircular canals.
The post-implantation evaluation uses the conventional treatment mode of the artificial vestibular implant device (providing head rotation speed information) and the placebo mode (fixed stimulation frequency and amplitude, independent of the patient's head movement).
The two stimulus modes were tested in random order on the same day, blinding the subjects and evaluators.
The effect of artificial vestibular implantation The results of this article suggest that the posture, gait and quality of life of the subjects have an overall improvement trend at 6 months and 1 year after unilateral artificial vestibular implantation; except for one subject, others All 7 subjects experienced postoperative hearing loss.
Figure 2.
Changes in dizziness, disability, and quality of life.
Adverse reactions during the follow-up of the subjects included: 1 case of the device was temporarily ineffective due to system software failure, resulting in two falls; 1 case of falling after the device was exhausted ; 1 case of falling and clavicle fracture occurred while riding a bicycle in the treatment mode of the device. In general, the research in this article is a study of artificial vestibular implantation based on patients' real life, chronic electrical stimulation, and long-term observation.
It is a milestone for the further research and improvement of this type of device.
The author introduces Professor Wu Hao, doctoral supervisor and chief physician.
He is currently the Dean of the Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine.
Academic part-time jobs include the chairman of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association, and the leader of the hearing screening expert group of the National Health Commission.
Long-term commitment to otology, otonic neurosurgery, and lateral skull base surgery related clinical and basic research, and has made important contributions in artificial hearing implant technology, acoustic neuroma treatment strategies, and pathogenesis, prevention and control strategies of sensorineural hearing loss Contributions have promoted the development of Otorhinolaryngology Head and Neck Surgery and Auditory Medicine in China.
Served as the chief scientist of key research and development projects of the Ministry of Science and Technology, and took the lead in undertaking a number of key projects of the National Natural Science Foundation of China.
He won the second prize of the National Science and Technology Progress Award in 2018 and the first prize of the Ministry of Education Science and Technology Progress Award in 2019 as the first completion person, and won the honorary titles of the young and middle-aged expert for outstanding contributions of the National Health and Family Planning Commission in 2017.
References 1.
Chow MR, Ayiotis AI, Schoo DP, et al.
Posture, gait, quality of life, and hearing with a vestibular implant.
N Engl J Med 2021; 384:521-532.
2.
Ward BK, Agrawal Y, Hoffman HJ, Carey JP, Della Santina CC.
Prevalence and impact of bilateral vestibular hypofunction: results from the 2008 US National Health Interview Survey.
JAMA Otolaryngol Head Neck Surg 2013;139:803-810.
3.
Elzen NGA, Tang KS, Allum JH.
The effect of prosthetic feedback on the strategies and synergies used by vestibular loss subjects to control stance.
J Neuroeng Rehabil 2013;10:115.
4.
Sienko KH, Whitney SL, Carender WJ, Wall C.
The role of sensory augmentation for people with vestibular deficits: realtime balance aid and/or rehabilitation device? J Vestib Res 2017;27:63-76.
5.
Fitzpatrick RC, Day BL.
Probing the human vestibular system with galvanic stimulation.
J Appl Physiol (1985) 2004;96:2301-2316.
6.
Barros CGC, Bittar RSM, Danilov Y.
Effects of electrotactile vestibular substitution on rehabilitation of patients with bilateral vestibular loss.
Neurosci Lett 2010;476:123-126.
7.
Golub JS, Ling L, Nie K, et al.
Prosthetic implantation of the human vestibular system.
Otol Neurotol 2014;35:136-147.
8.
Phillips JO, Ling L, Nie K, et al.
Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects.
J Neurophysiol 2015;113:3866-3892.
Copyright information Call for drafts.
Prosthetic implantation of the human vestibular system.
Otol Neurotol 2014;35:136-147.
8.
Phillips JO, Ling L, Nie K, et al.
Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects.
J Neurophysiol 2015;113 :3866-3892.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
Prosthetic implantation of the human vestibular system.
Otol Neurotol 2014;35:136-147.
8.
Phillips JO, Ling L, Nie K, et al.
Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects.
J Neurophysiol 2015;113 :3866-3892.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM). The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
8 million adults worldwide suffer from severe bilateral vestibular dysfunction, which is mainly manifested as chronic balance disorder, vibration hallucinations, gait instability and even falls, which seriously affect the lives and physical and mental health of patients.
The traditional treatment of the disease mainly uses vestibular rehabilitation exercises and vestibular stimulation treatments (sound, vibration, electrical stimulation, etc.
), but these treatments are not helpful for gait improvement.
The New England Journal of Medicine published on February 11, 2021, the Johns Hopkins University School of Medicine team on the clinical effect of artificial vestibular implantation in 8 patients with bilateral vestibular dysfunction.
This study is the first to show in daily life that artificial implantation devices have significantly improved the patient's balance, gait stability and quality of life through long-term follow-up, marking an important new development in the field of vestibular medicine.
We invited Professor Wu Hao, chairman of the Otorhinolaryngology Head and Neck Surgery Branch of the Chinese Medical Association and dean of the Ninth People’s Hospital of Shanghai Jiaotong University School of Medicine, to interpret this paper.
To read the full text translation, please visit NEJM Medical Frontier's official website, APP or click on the picture of the WeChat applet.
Wu Hao, Department of Otorhinolaryngology, Head and Neck Surgery, the Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, led by Professor Della Santina’s team in Otorhinolaryngology Head and Neck Surgery, Johns Hopkins University School of Medicine, used artificial labor developed by Labyrinth Devices and Med-El.
The vestibular implant device is implanted into the patient's inner ear to perform chronic electrical stimulation on the vestibular nerve branches in the three semicircular canals.
After 1 year of follow-up, the author reported that unilateral vestibular implantation can improve the posture, gait and quality of life of patients with bilateral vestibular dysfunction, and achieved satisfactory results.
Although 7 out of 8 implanters had hearing loss on the implant side, this technology still provides a new treatment for bilateral vestibular dysfunction.
What is artificial vestibular implantation.
The vestibule is the most important balance receptor in the human body, which combines visual and proprioceptive systems to maintain body posture.
The vestibule is located in the inner ear and includes three semicircular canals, an utricle and a balloon.
The semicircular canals sense the angular acceleration of the body's rotation, and the utricle and balloon sense the linear acceleration of the body.
Impairment of vestibular function will affect the body's balance function, posture control, etc.
, resulting in corresponding clinical symptoms.
Since it is found that electrical stimulation of the vestibular ampulla nerve can induce eye movements, in theory, artificial electrical signal stimulation of the corresponding structure may replace the body's sensory function and restore or partially restore the vestibular function.
At present, this kind of functional replacement mainly adopts three methods: cochlear implantation to co-stimulate the vestibule, artificial vestibular implantation to stimulate the vestibule, and non-implantable electrical stimulation.
Figure 1.
The components and mechanism of the vestibular implant device.
This article uses an artificial vestibular implant to electrically stimulate the vestibule.
The device is modified on the basis of a cochlear implant and adds an electrode array to achieve electrical stimulation of three semicircular canals.
, Can continue to give bidirectional current pulses, the rate and amplitude of the current pulses depend on the head rotation speed and axis direction.
The device includes: an external head-mounted unit for sensing head rotation (three components, each component corresponding to a semicircular canal), and transmitting a signal to the internal processor through the coil percutaneously; internal implanting unit, including implant The electrodes into the semicircular canal, as well as the power supply and micro-processing control unit that contain the battery and store the stimulation settings and control the pulses.
Compared with cochlear implantation, artificial vestibular implantation surgery is slightly more difficult.
At present, there are mainly two types of labyrinth inner approach and labyrinth outer approach.
The inner labyrinth approach requires opening the bony labyrinth and implanting electrodes into the perilymph space/ampullary of the semicircular canal; the outer labyrinth approach places the electrodes on the vestibular nerve outside the labyrinth or even directly on the Scarpa ganglion.
Both methods can achieve electrical evoked vestibular response, but the labyrinthine approach has a higher risk of residual hearing loss.
Although most vestibular implant subjects have severe hearing loss, for people with bilateral vestibular disease, hearing protection still needs additional attention.
Although there is a certain risk of sensory nerve and conductive hearing loss as well as facial nerve damage to the labyrinthic outer path, the electrode is placed closer to the target point and the effective stimulation current may be smaller.
In this paper, the labyrinthine internal approach is adopted.
A small hole with a diameter of about 0.
6 mm is made at the ampulla of each semicircular canal.
The electrode array is implanted and sealed with fascia and bone meal.
The reference electrode is placed on the total leg of the labyrinthine semicircular canal or implanted body capsule.
At the bag.
The clinical research on artificial vestibular implantation has been reported since 2007, but most of them were performed with acute or intermittent electrical stimulation.
Only the team in this article implemented chronic electrical stimulation and conducted a 1-year period of electrical stimulation.
Follow-up, and the patient used it both at the research center and at home.
Because only in this case, can the use analysis in the real daily environment be carried out.
This is also the characteristic of this research.
Study Design This study is a prospective, single-center, non-randomized, single-group, self-controlled study.
After recruiting patients with indications and eliminating contraindications, collect the patient's related posture and gait, dizziness and exercise ability, quality of life, and hearing conditions within a week before surgery, and perform it again at 3 weeks, 6 months, and 1 year after implantation Evaluation.
After implantation, the device operates for 24 hours and continuously stimulates the 3 semicircular canals.
The post-implantation evaluation uses the conventional treatment mode of the artificial vestibular implant device (providing head rotation speed information) and the placebo mode (fixed stimulation frequency and amplitude, independent of the patient's head movement).
The two stimulus modes were tested in random order on the same day, blinding the subjects and evaluators.
The effect of artificial vestibular implantation The results of this article suggest that the posture, gait and quality of life of the subjects have an overall improvement trend at 6 months and 1 year after unilateral artificial vestibular implantation; except for one subject, others All 7 subjects experienced postoperative hearing loss.
Figure 2.
Changes in dizziness, disability, and quality of life.
Adverse reactions during the follow-up of the subjects included: 1 case of the device was temporarily ineffective due to system software failure, resulting in two falls; 1 case of falling after the device was exhausted ; 1 case of falling and clavicle fracture occurred while riding a bicycle in the treatment mode of the device. In general, the research in this article is a study of artificial vestibular implantation based on patients' real life, chronic electrical stimulation, and long-term observation.
It is a milestone for the further research and improvement of this type of device.
The author introduces Professor Wu Hao, doctoral supervisor and chief physician.
He is currently the Dean of the Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine.
Academic part-time jobs include the chairman of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association, and the leader of the hearing screening expert group of the National Health Commission.
Long-term commitment to otology, otonic neurosurgery, and lateral skull base surgery related clinical and basic research, and has made important contributions in artificial hearing implant technology, acoustic neuroma treatment strategies, and pathogenesis, prevention and control strategies of sensorineural hearing loss Contributions have promoted the development of Otorhinolaryngology Head and Neck Surgery and Auditory Medicine in China.
Served as the chief scientist of key research and development projects of the Ministry of Science and Technology, and took the lead in undertaking a number of key projects of the National Natural Science Foundation of China.
He won the second prize of the National Science and Technology Progress Award in 2018 and the first prize of the Ministry of Education Science and Technology Progress Award in 2019 as the first completion person, and won the honorary titles of the young and middle-aged expert for outstanding contributions of the National Health and Family Planning Commission in 2017.
References 1.
Chow MR, Ayiotis AI, Schoo DP, et al.
Posture, gait, quality of life, and hearing with a vestibular implant.
N Engl J Med 2021; 384:521-532.
2.
Ward BK, Agrawal Y, Hoffman HJ, Carey JP, Della Santina CC.
Prevalence and impact of bilateral vestibular hypofunction: results from the 2008 US National Health Interview Survey.
JAMA Otolaryngol Head Neck Surg 2013;139:803-810.
3.
Elzen NGA, Tang KS, Allum JH.
The effect of prosthetic feedback on the strategies and synergies used by vestibular loss subjects to control stance.
J Neuroeng Rehabil 2013;10:115.
4.
Sienko KH, Whitney SL, Carender WJ, Wall C.
The role of sensory augmentation for people with vestibular deficits: realtime balance aid and/or rehabilitation device? J Vestib Res 2017;27:63-76.
5.
Fitzpatrick RC, Day BL.
Probing the human vestibular system with galvanic stimulation.
J Appl Physiol (1985) 2004;96:2301-2316.
6.
Barros CGC, Bittar RSM, Danilov Y.
Effects of electrotactile vestibular substitution on rehabilitation of patients with bilateral vestibular loss.
Neurosci Lett 2010;476:123-126.
7.
Golub JS, Ling L, Nie K, et al.
Prosthetic implantation of the human vestibular system.
Otol Neurotol 2014;35:136-147.
8.
Phillips JO, Ling L, Nie K, et al.
Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects.
J Neurophysiol 2015;113:3866-3892.
Copyright information Call for drafts.
Prosthetic implantation of the human vestibular system.
Otol Neurotol 2014;35:136-147.
8.
Phillips JO, Ling L, Nie K, et al.
Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects.
J Neurophysiol 2015;113 :3866-3892.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
Prosthetic implantation of the human vestibular system.
Otol Neurotol 2014;35:136-147.
8.
Phillips JO, Ling L, Nie K, et al.
Vestibular implantation and longitudinal electrical stimulation of the semicircular canal afferents in human subjects.
J Neurophysiol 2015;113 :3866-3892.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM). The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
