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Device development guided by user satisfaction survey on auricular vagus nerve stimulation

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Current Directions in Biomedical Engineering
From the journal Current Directions in Biomedical Engineering Volume 2 Issue 1

Abstract

Development of wearable point-of-care medical devices faces many challenges. Besides technological and clinical issues, demands on robustness, miniaturization, and user interface design are of paramount importance. However, a systematic assessment of these non-functional but essential requirements is often impossible within the first product cycle. Later, surveys on user satisfaction with existing devices and user demands can offer significant input for device re-development and improvement. In this paper, we present a survey on satisfaction with and demands for a wearable medical device for percutaneous auricular vagus nerve stimulation (pVNS). We analyzed 36 responses from patients treated with pVNS and five responses from experienced physicians in order to devise a future concept of pVNS. Main shortcomings of a current pVNS device were identified to be lacking water resistance and mechanical robustness, both impairing daily activities. Painful sensation during pVNS application, unwanted side effects like skin irritations and strongly varying perception of the stimulation were reported. Results urge for more patient self-governance and an (automatic) adjustment of the stimulation to the current physiological state of the patient. Attained results support a strategic approach for future developments of pVNS towards personalized health care.

Keywords: auricular vagus nerve stimulation; medical device development; personalized healthcare; satisfaction; survey

1 Introduction

Electrical stimulation of the vagus nerve is increasingly recognized as an effective treatment in a variety of disorders. Today, invasive stimulation techniques targeting the cervical vagus nerve are utilized, e.g. in the treatment of refractory epilepsy [1]. Remarkable results can be achieved, but the method comes with risks of major surgery and side effects. Recently, a more subtle stimulation method has been investigated, which aims at the modulation of the auricular branch of the vagus nerve in the ear [2]. The percutaneous auricular vagus nerve stimulation (pVNS) advantageously avoids risks/costs of surgery and allows for a selective stimulation of afferent nerve fibers [3]. pVNS is already in clinical use for >10 years mainly for pain management and the treatment of peripheral perfusion dysfunction.

Current single-use pVNS devices apply three needle electrodes in the auricle to stimulate afferent nerve fibers [2]. An additional reference electrode is required, which is affixed by an adhesive at the neck of the patient (see Figure 1A). Stimulation is performed continuously over several days and can be extended by changing the device each week. However, the current pVNS treatment is suboptimal. The implemented fixed stimulation pattern leads to undesired effects due to highly patient-specific reactions to pVNS. Recent studies indicate that the stimulation pattern affects therapeutic outcome and emphasises the need for a patient-specific stimulation pattern adjustment [3], [4]. Our personal communication with patients has also revealed deficiencies in wearability and operability of current pVNS devices.

Figure 1: Schemes of body-worn medical devices for percutaneous auricular vagus nerve stimulation using three needle electrodes in the ear. (A) Current concept with simple and fixed stimulation parameters, limited battery life-time and adhesive reference electrode. (B) Future concept with individualized, feedback controlled stimulation parameters (e.g. by feedback of heart rate HR), extended battery life-time and watertight casing.
Figure 1:

Schemes of body-worn medical devices for percutaneous auricular vagus nerve stimulation using three needle electrodes in the ear. (A) Current concept with simple and fixed stimulation parameters, limited battery life-time and adhesive reference electrode. (B) Future concept with individualized, feedback controlled stimulation parameters (e.g. by feedback of heart rate HR), extended battery life-time and watertight casing.

For these reasons, we focus on the development of a novel personalized and body-worn pVNS device addressing these limitations, especially the high inter-patient variability. Focusing on personalized healthcare, it is essential to consider not only technological and clinical aspects during the early design phase, but also experiences and demands of users, i.e. patients and operators. In this context, patient surveys on satisfaction with medical devices, e.g. in the field of feedback controlled upper arm prostheses [5], can provide tremendous insight into current deficiencies of treatment while creating essential input for device development and improvement. Here a survey is presented with the major goal to identify aspects of improvement of current pVNS treatment in terms of improved stimulation methods as well as refined user interface, mechanical design, and application.

2 Method

The developed survey for patients (n = 40) and operators (n = 5, physicians) includes 61 questions on general data, satisfaction with current treatment, and demands for future treatment. Data on current treatment (Figure 1A) included satisfaction with pVNS treatment, effects and perception of treatment, and satisfaction with the device application. Data for future pVNS treatment (Figure 1B) was assessed, which concerned the device design, application and operation.

The respondent’s statements were measured using single-choice or multiple-choice questions, five-level ordinal scales and five-level or ten-level interval scales. Open ended questions were used when closed questions could not account for the variety of expected responses. This also allows the respondents to bring in new ideas for development. The questions were designed for easy comprehension. Pretesting of the questionnaire was based on qualitative laboratory techniques. Single questions were evaluated by subject matter experts [6]. The completed questionnaire was evaluated in an expert review [7] and revised by a social scientist experienced in survey design. The questionnaire was filled by three users applying concurrent think aloud, follow-up probing and debriefing questions [8], [9].

Users were recruited from a special outpatient clinic at the Medical University Vienna, University Clinic for Surgery. Patients were included if they underwent at least one treatment with pVNS (P-Stim, Biegler GmbH, Austria). Surveys were distributed in paper form. All data processing and statistical analysis were performed using MATLAB R2014b (The Mathworks Inc., Natick, MA, USA). When appropriate, responses to interval scales are represented by mean ± standard deviation.

3 Results

From 40 questionnaires for patients 36 (90%) were completed and fulfilled the inclusion criterion. In addition, five questionnaires were completed by operators aged 32.25 ± 12.9 years (50% female) having experience with pVNS therapy of at least 6 months. Responding patients were aged 57.2 ± 17.4 years (25% female) and suffered from chronic lower extremity ulcers (41.7%), chronic pain (33.3%), neurological disorders (25%), acute pain (19.4%), peripheral arterial occlusive disease (8.3%) and other diseases (8.3%) with a history of the disease of 6.1 ± 6.4 years (the total range from 2 weeks to 28 years). Treatment durations of included patients range from 1 week up to 10 years. 48.6% of patients tried other therapies before pVNS treatment with a satisfaction rate of only 22.4%.

3.1 Satisfaction with therapy

Considering overall treatment satisfaction, 82.3% of patients are (very) satisfied, 17.6% sign for neutral and nobody is very dissatisfied or not satisfied. Patients report an improvement in life quality due to pVNS therapy of 1.7 ± 2.8 on a 10 point interval scale from very bad to very good.

Although satisfaction is high, 41.2% of all patients report unwanted side effects (at least once during treatment). This mainly accounts for skin irritation at neck (60%) and ear (26.7%), pain (26.7%), inflammation (20%), bleeding at ear (13.3%), and slight dizziness (13.3%).

Concerning activities of daily living (Figure 2), the device application dominantly influences personal hygiene and sleeping, where 31% and 21.4% of the patients report (very) negative influence, respectively.

Figure 2: Influence through current pVNS application on patients’ activities of daily living.
Figure 2:

Influence through current pVNS application on patients’ activities of daily living.

Only 51.6%, 56.3% and 54.9% of all patients are (very) satisfied with the application of the needle electrodes, wires and the device itself, respectively (Figure 3). Mechanical characteristics of the device seem to be satisfactory (Figure 3). Patients prove a good mobility with the applied device, 85.3% are neutral or (very) satisfied. Operators are most unsatisfied by the placement of the wires (too stiff) and the device with 33.3% each. Application of needles was reported to be painful on an interval scale from 0 to 10 (no pain to intolerable pain) with 3.5 ± 1.4 (Figure 4). On the same scale, patients perceive the initial stimulation amplitude as 4.7 ± 1.5 (Figure 4). Only 5.9% of all patients report a desirable comfortable feeling of stimulation. A largely varying perception was observed, which may influence therapeutic outcome heavily.

Figure 3: Patient satisfaction with the current pVNS device: device, wire, and needle mounting as well as weight and size of the device and mobility with the device.
Figure 3:

Patient satisfaction with the current pVNS device: device, wire, and needle mounting as well as weight and size of the device and mobility with the device.

Concerning the therapy duration, a continuous stimulation over about 4 days is aimed at with the current pVNS device. Mean duration of the perception was answered to be 3.4 ± 0.9 days, whereas patients report a decrease in sensibility over longer periods of treatment. In 70.5% and 48.8% of all cases the device and the needles detached before 4 days at least once, respectively. In 25.7% of cases patients accidentally detached the device during activities of daily living.

3.2 Demands for therapy

Patients and operators declared no clear preference concerning the mounting regions of the device. 80.5% of patients want the device fixed with an adhesive at a position near the ear (66.6%), in contrast to hanging it over the ear or the neck. Patients would also accept a placement on the chest, back or the upper arm. There is no clear preference of patients and operators concerning the shape of the device. One fundamental shortcoming of the current device was identified to be the missing robustness for water, since all patients and operators claim the need for the device to be watertight, and thus enable, e.g. showering.

Concerning the user interface, several possibilities of device operation were offered to patients and operators. 81.1% and 100% of all patients and operators, respectively, want to adjust the stimulation amplitude in accordance with the momentary perception. 84.4% of patients and 60% of operators want the stimulation amplitude to be adjustable by both patient and operator. There is no preference for any asked means of interaction with the device (e.g. by buttons). 40.5% and 72.2% of all patients want to disable or take off the device, respectively, in specific situations like showering or when they need to be concentrated, like during car driving.

An important boundary condition for an effective therapy is the required time interval between two pVNS applications, which depends strongly on the particular disease of the patient and is limited by battery lifetime of the device. On average, patients suggest a time interval between two consecutive treatments of 9.4 days with a range from 3 (wound treatment) up to 21 (chronic pain treatment) days. The device application should not exceed 24.0 min. Operators wish to have durations of 9.5 days between two applications and want a single application of the device not to take longer than 16.6 min.

With respect to new device developments towards patient-governed or automatic feedback-based control of stimulation parameters, it may be necessary to motivate the patient to perform additional measurements and/or to use or wear additional devices (e.g. to measure heart rate). Of all patients, 34.4% are willing to perform such additional measurements whereas 40.6% are likely willing, with the limitation of a maximum of 23.27 min per day. However, the motivation to continuously wear an additional device is lower, with 21.9% and 37.5% of all patients, respectively.

Open questions for potential improvements identified the following main shortcomings: limited battery life time, lacking resistance to water, missing flexible design with soft cables, and missing autonomy of the patient and operator (e.g. stimulation amplitude). On the other hand, patients and operators are attracted by the minimal-invasive nature of pVNS, as there are no pharmaceutical components involved and thus there are no pharmaceutical side effects.

4 Discussion

Although >80% of patients are satisfied with pVNS treatment, the given survey identified potential for its improvement.

From a technological point of view, attained results encourage further improvements for the device design (Figure 1B). Miniaturization seems not to be a relevant issue, as patients are happy with the current weight and size of the pVNS device. However, miniaturization may reduce disturbance during daily activities. The adhesive area of the device constitutes a major problem as it serves as the reference electrode for stimulation and its detachment is critical and terminates pVNS. The adhesive is also the main cause for unwanted side effects, namely skin irritation. Transferring the reference electrode from the neck to the ear (with an additional needle) or by using specific stimulation patterns (which do not need the reference electrode due to specific current steering concepts) could account for these issues. The resulting requirements for the adhesive are then less restricting and a targeted extended wear time of about 10–14 days may be achieved. Concerning mechanical device design water tightness is crucial for wearing comfort.

From a biophysical and therapeutic point of view, it is necessary to enable the device to adjust its stimulation amplitude. The therapeutic concept of pVNS is based on the selective stimulation of thick afferent Aβ-fibers of the auricular vagus nerve [2]. For this, a tingling sensation of the stimulation is aimed at. As only 5.9% of all patients report a desirable comfortable sensation, the operator and patient need to adjust the stimulation amplitude. More than 20% of the patients feel the stimulation too intensive (Figure 4), thus personal adaptation of the strength will not only cause more specific fibre activation but will also reduce overstimulation, adaptation of perception, and energy consumption.

Figure 4: Pain perception of patients during device mounting prior to operation and perception of initial stimulation strength.
Figure 4:

Pain perception of patients during device mounting prior to operation and perception of initial stimulation strength.

Concerning the operation of the device, the majority of patients and operators want to be able to switch/take off the device in certain situations, e.g. during showering or car driving. This may be a problem concerning therapeutic efficiency, as patients may reduce total stimulation time. Such feature is therefore debateable and might require fixed minimum stimulation duration per day. Interestingly, operators and patients tend towards more patient self-governance with the patient having the ability/responsibility to adjust stimulation parameters with respect to their health state. However, this is obviously not straight forward. Firstly, there is not enough data to identify specific parameters in the necessary granularity for an adjustment yet; secondly, patients would need certain knowledge about the function of the device. This emphasises the need for future development of automated feedback-controlled stimulation. The feedback may be implemented using different biophysical markers, from heart rate or heart rate variability to chemical markers.

From a methodological point of view, the survey may be biased by the selection of patients, as mainly patients with typically good compliance were selected. Thus, it may be difficult to draw conclusions for the whole population.

Our results show that surveys on user demands can provide essential input for device development. Based on the gathered data, mechanical device design, user interface design but also biophysical issues gained foundation and an optimized device development is promoted.

Acknowledgement

We thank Bettina Jager for unlimited support during questionnaire design and all respondents.

Author’s Statement

Research funding: This research was partly supported by the Austrian Research Promotion Agency (Proj.-Nr.: 853701). Conflict of interest: S. Kampusch, E. Kaniusas and J.C. Szëles are shareholders of SzeleSTIM GmbH. Informed consent: Informed consent has been obtained from all individuals included in this study. Ethical approval: The research related to human use complies with all the relevant national regulations, institutional policies and was performed in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.

References

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Published Online: 2016-9-30
Published in Print: 2016-9-1

©2016 Stefan Kampusch et al., licensee De Gruyter.

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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https://doi.org/10.1515/cdbme-2016-0131
Keywords for this article
auricular vagus nerve stimulation; medical device development; personalized healthcare; satisfaction; survey
Creative Commons
BY-NC-ND 4.0

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  51. Derivation of the respiratory rate from directly and indirectly measured respiratory signals using autocorrelation
  52. Left cardiac atrioventricular delay and inter-ventricular delay in cardiac resynchronization therapy responder and non-responder
  53. An automatic systolic peak detector of blood pressure waveforms using 4th order cumulants
  54. Real-time QRS detection using integrated variance for ECG gated cardiac MRI
  55. Preprocessing of unipolar signals acquired by a novel intracardiac mapping system
  56. In-vitro experiments to characterize ventricular electromechanics
  57. Continuous non-invasive monitoring of blood pressure in the operating room: a cuffless optical technology at the fingertip
  58. Application of microwave sensor technology in cardiovascular disease for plaque detection
  59. Artificial blood circulatory and special Ultrasound Doppler probes for detecting and sizing gaseous embolism
  60. Detection of microsleep events in a car driving simulation study using electrocardiographic features
  61. A method to determine the kink resistance of stents and stent delivery systems according to international standards
  62. Comparison of stented bifurcation and straight vessel 3D-simulation with a prior simulated velocity profile inlet
  63. Transient Euler-Lagrange/DEM simulation of stent thrombosis
  64. Automated control of the laser welding process of heart valve scaffolds
  65. Automation of a test bench for accessing the bendability of electrospun vascular grafts
  66. Influence of storage conditions on the release of growth factors in platelet-rich blood derivatives
  67. Cryopreservation of cells using defined serum-free cryoprotective agents
  68. New bioreactor vessel for tissue engineering of human nasal septal chondrocytes
  69. Determination of the membrane hydraulic permeability of MSCs
  70. Climate retainment in carbon dioxide incubators
  71. Multiple factors influencing OR ventilation system effectiveness
  72. Evaluation of an app-based stress protocol
  73. Medication process in Styrian hospitals
  74. Control tower to surgical theater
  75. Development of a skull phantom for the assessment of implant X-ray visibility
  76. Surgical navigation with QR codes
  77. Investigation of the pressure gradient of embolic protection devices
  78. Computer assistance in femoral derotation osteotomy: a bottom-up approach
  79. Automatic depth scanning system for 3D infrared thermography
  80. A service for monitoring the quality of intraoperative cone beam CT images
  81. Resectoscope with an easy to use twist mechanism for improved handling
  82. In vitro simulation of distribution processes following intramuscular injection
  83. Adjusting inkjet printhead parameters to deposit drugs into micro-sized reservoirs
  84. A flexible standalone system with integrated sensor feedback for multi-pad electrode FES of the hand
  85. Smart control for functional electrical stimulation with optimal pulse intensity
  86. Tactile display on the remaining hand for unilateral hand amputees
  87. Effects of sustained electrical stimulation on spasticity assessed by the pendulum test
  88. An improved tracking framework for ultrasound probe localization in image-guided radiosurgery
  89. Improvement of a subviral particle tracker by the use of a LAP-Kalman-algorithm
  90. Learning discriminative classification models for grading anal intraepithelial neoplasia
  91. Regularization of EIT reconstruction based on multi-scales wavelet transforms
  92. Assessing MRI susceptibility artefact through an indicator of image distortion
  93. EyeGuidance – a computer controlled system to guide eye movements
  94. A framework for feedback-based segmentation of 3D image stacks
  95. Doppler optical coherence tomography as a promising tool for detecting fluid in the human middle ear
  96. 3D Local in vivo Environment (LivE) imaging for single cell protein analysis of bone tissue
  97. Inside-Out access strategy using new trans-vascular catheter approach
  98. US/MRI fusion with new optical tracking and marker approach for interventional procedures inside the MRI suite
  99. Impact of different registration methods in MEG source analysis
  100. 3D segmentation of thyroid ultrasound images using active contours
  101. Designing a compact MRI motion phantom
  102. Cerebral cortex classification by conditional random fields applied to intraoperative thermal imaging
  103. Classification of indirect immunofluorescence images using thresholded local binary count features
  104. Analysis of muscle fatigue conditions using time-frequency images and GLCM features
  105. Numerical evaluation of image parameters of ETR-1
  106. Fabrication of a compliant phantom of the human aortic arch for use in Particle Image Velocimetry (PIV) experimentation
  107. Effect of the number of electrodes on the reconstructed lung shape in electrical impedance tomography
  108. Hardware dependencies of GPU-accelerated beamformer performances for microwave breast cancer detection
  109. Computer assisted assessment of progressing osteoradionecrosis of the jaw for clinical diagnosis and treatment
  110. Evaluation of reconstruction parameters of electrical impedance tomography on aorta detection during saline bolus injection
  111. Evaluation of open-source software for the lung segmentation
  112. Automatic determination of lung features of CF patients in CT scans
  113. Image analysis of self-organized multicellular patterns
  114. Effect of key parameters on synthesis of superparamagnetic nanoparticles (SPIONs)
  115. Radiopacity assessment of neurovascular implants
  116. Development of a desiccant based dielectric for monitoring humidity conditions in miniaturized hermetic implantable packages
  117. Development of an artifact-free aneurysm clip
  118. Enhancing the regeneration of bone defects by alkalizing the peri-implant zone – an in vitro approach
  119. Rapid prototyping of replica knee implants for in vitro testing
  120. Protecting ultra- and hyperhydrophilic implant surfaces in dry state from loss of wettability
  121. Advanced wettability analysis of implant surfaces
  122. Patient-specific hip prostheses designed by surgeons
  123. Plasma treatment on novel carbon fiber reinforced PEEK cages to enhance bioactivity
  124. Wear of a total intervertebral disc prosthesis
  125. Digital health and digital biomarkers – enabling value chains on health data
  126. Usability in the lifecycle of medical software development
  127. Influence of different test gases in a non-destructive 100% quality control system for medical devices
  128. Device development guided by user satisfaction survey on auricular vagus nerve stimulation
  129. Empirical assessment of the time course of innovation in biomedical engineering: first results of a comparative approach
  130. Effect of left atrial hypertrophy on P-wave morphology in a computational model
  131. Simulation of intracardiac electrograms around acute ablation lesions
  132. Parametrization of activation based cardiac electrophysiology models using bidomain model simulations
  133. Assessment of nasal resistance using computational fluid dynamics
  134. Resistance in a non-linear autoregressive model of pulmonary mechanics
  135. Inspiratory and expiratory elastance in a non-linear autoregressive model of pulmonary mechanics
  136. Determination of regional lung function in cystic fibrosis using electrical impedance tomography
  137. Development of parietal bone surrogates for parietal graft lift training
  138. Numerical simulation of mechanically stimulated bone remodelling
  139. Conversion of engineering stresses to Cauchy stresses in tensile and compression tests of thermoplastic polymers
  140. Numerical examinations of simplified spondylodesis models concerning energy absorption in magnetic resonance imaging
  141. Principle study on the signal connection at transabdominal fetal pulse oximetry
  142. Influence of Siluron® insertion on model drug distribution in the simulated vitreous body
  143. Evaluating different approaches to identify a three parameter gas exchange model
  144. Effects of fibrosis on the extracellular potential based on 3D reconstructions from histological sections of heart tissue
  145. From imaging to hemodynamics – how reconstruction kernels influence the blood flow predictions in intracranial aneurysms
  146. Flow optimised design of a novel point-of-care diagnostic device for the detection of disease specific biomarkers
  147. Improved FPGA controlled artificial vascular system for plethysmographic measurements
  148. Minimally spaced electrode positions for multi-functional chest sensors: ECG and respiratory signal estimation
  149. Automated detection of alveolar arches for nasoalveolar molding in cleft lip and palate treatment
  150. Control scheme selection in human-machine- interfaces by analysis of activity signals
  151. Event-based sampling for reducing communication load in realtime human motion analysis by wireless inertial sensor networks
  152. Automatic pairing of inertial sensors to lower limb segments – a plug-and-play approach
  153. Contactless respiratory monitoring system for magnetic resonance imaging applications using a laser range sensor
  154. Interactive monitoring system for visual respiratory biofeedback
  155. Development of a low-cost senor based aid for visually impaired people
  156. Patient assistive system for the shoulder joint
  157. A passive beating heart setup for interventional cardiology training
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