Evaluating Comfort and Efficacy: A Comprehensive Analysis of ECAP-Controlled Closed-Loop Spinal Cord Stimulation from Patient Perspectives

doi:10.21203/rs.3.rs-5252852/v1

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Evaluating Comfort and Efficacy: A Comprehensive Analysis of ECAP-Controlled Closed-Loop Spinal Cord Stimulation from Patient Perspectives

https://doi.org/10.21203/rs.3.rs-5252852/v1

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Rechargeable implantable generators (r-IPGs) have been used in spinal cord stimulation (SCS) for chronic pain treatment since 2004, offering longer lifespans compared to traditional devices. Closed-loop SCS (CL-SCS) systems, which use neurobiological feedback to regulate spinal cord activation, rely on r-IPGs for power. However, there is limited data on the long-term performance of these devices, including the ease of recharging and potential interruptions during the process. To address these gaps, a study was conducted using a 48-item questionnaire distributed to chronic pain patients with CL-SCS devices. Results from 8 patients indicated that the recharging process was generally considered very easy, with an average charge burden of just over three hours per week. Most patients felt confident managing their neurostimulators, though one patient reported interruptions during recharging. These findings suggest that while CL-SCS systems require more effort compared to conventional devices, they offer greater comfort and fewer issues related to recharging and interruption. This early data highlights the need for larger studies comparing CL-SCS with conventional SCS systems to further evaluate patient convenience and device performance.

Biological sciences/Neuroscience/Diseases of the nervous system/Chronic pain

Biological sciences/Neuroscience/Peripheral nervous system

spinal cord stimulation

implantable pulse generators

rechargeable pulse generators

questionnaire-based

closed-loop

Spinal cord stimulation (SCS) is a widely recognized treatment method for relieving chronic pain. It involves delivering electrical signals to dorsal columns of the spinal cord to stimulate specific nerve fibers, such as Aβ fibers 1^,2. This activation inhibits pain signals in the dorsal horn of the spinal cord, resulting in perceived pain reduction. Despite being described about 50 years ago, the precise mechanics behind SCS are still not well understood 3. Within the field of neurostimulation devices, prior assessments have predominantly concentrated on open-loop spinal cord stimulation (OL-SCS), which delivers continuous and unchanging stimulation without the capacity to modify dosages according to real-time physiological data. The absence of consistent monitoring and fine-tuning of the level of stimulation intensity leads to notable variations in the activation of the spinal cord due to movement and position dependent variance in the distance between epidural stimulation electrodes and the intradural nerve structures, which in turn affects the efficacy of pain alleviation. Furthermore, open-loop devices do not effectively evaluate the spinal cord's reaction to stimulation, impeding the confirmation of therapy administration to the neurons accountable for pain suppression pathways 4^,5.

Recent research has led to the development of closed-loop spinal cord stimulation (CL-SCS), a technique that uses evoked compound action potentials (ECAPs) to accurately quantify the activation of sensory nerve fibers in response to each pulse of stimulation 6^,7. Contrary to open-loop systems, CL-SCS enables the immediate modification of stimulation levels, guaranteeing a steady activation of the spinal cord even in the presence of physiological variations. This physiological regulatory characteristic can augment pain relief by stimulating pain-suppressing pathways 8^,9.

The EVOKE Study, an extensive research undertaking, was a double-blind, randomized, multicenter protocol to compare CL-SCS with OL-SCS. The closed-loop group demonstrated significantly greater and more clinically meaningful pain relief at both 3 months (82.3% vs. 60.3%) and 12 months (83.1% vs. 61.0%) compared to the open-loop group. The results exhibited significant enhancements in multiple domains, encompassing primary and long-term pain relief as well as secondary indicators such as physical and emotional well-being, and health-related quality of life (QOL). This study provides evidence of the safety and significantly superior clinical efficacy of the novel closed-loop system, emphasizing the potential for a mechanism-based, personalized therapy in the field of neuromodulation 10^,11.

Brooker et al. conducted a comprehensive 24-month study involving 50 participants to determine the efficacy of CL-SCS devices. CL-SCS provided effective pain, even as opioid use and the need for reprogramming decreased. A remarkable 89.5% of participants achieved at least a 50% reduction in overall pain. These results represent a continued improvement from the 3-month and 12-month assessments. Furthermore, over 80% of patients experienced a clinically meaningful improvement in QOL, and more than 50% exhibited a significant enhancement in sleep quality. Notably, more than 82.8% of patients who initially used opioids either reduced or eliminated their intake, with 41.4% discontinuing opioid use altogether. As a result of these findings, CL-SCS has proven to be a highly effective method of managing chronic pain, as well as helping reduce opioid abuse and improving overall health 9.

Although CL-SCS devices show potential for pain management, they also bring about additional factors to be considered by patients and healthcare professionals. When evaluating the possibility of CL-SCS implantation for persons with chronic pain conditions, it is critical to carefully analyze factors such as the charging procedure, which requires increased attention and manual cognitive abilities 12. Currently, there are no globally recognized criteria for assessing closed-loop-device appropriateness. Decisions on suitability are influenced by aspects such as age, cognitive and physical ability, level of stimulation, and associated costs.

The main aim of this study is to assess patients' opinions regarding the ease of wearing and charging, user confidence, and overall satisfaction, including their level of contentment with the CL-SCS system beyond the charging process.

2.1. Trial

The Recharge Pain Trial was conceived as a monocentric, questionnaire-based observational study.

2.2. Patients

All adult patients (age ≥ 18 years) with chronic pain syndromes who underwent active CL-SCS (Evoke System; Saluda Medical) treatment at the Department of Neurosurgery at Heidelberg University Hospital since 2020 were included. Exclusion criteria encompass individuals unable to comprehend the study information or provide informed consent. Additionally, those facing acute or severe psychiatric conditions that could impede compliance with study procedures are excluded. The exclusion criteria also extend to any medical or psychological conditions that, according to the investigator's judgment, might compromise a patient's ability to participate in the study actively. These criteria ensure that participants possess the necessary cognitive and psychological capacities to engage meaningfully with the study requirements and procedures.

2.3. Design and procedure

Patients who met the specified inclusion criteria were provided with a study kit containing detailed trial information, the informed consent form, the questionnaire, and a stamped return envelope. The return of a questionnaire and a signed informed consent form within six weeks was required for inclusion in the data analysis. The information gathered from the questionnaires was anonymized and transferred to a trial database using Microsoft® Excel Version 16.55 (Microsoft Corporation, Redmond, WA, USA). Additional clinical details, such as diagnosis, primary or secondary implant, stimulator localization, and surgery date, were extracted from hospital charts.

2.4. Questionnaire design

The questionnaire consisted of 48 questions covering various aspects of managing a rechargeable CL-SCS device (see the Appendix for details). The questions presented were a combination of open- and closed-ended, with two or more possible answers. Participants were asked to assess the convenience of charging and the overall effort involved, utilizing an ordinal scale ranging from 1 to 100 (where 100 = very hard/very high and 1 = very easy/very low).

2.5. Statistical analysis

Descriptive statistics, including mean, standard deviation, and range, were employed for continuous variables such as age. In cases where the data were ordinal, like recharging convenience, the median was calculated. To assess significant differences between two means of continuous variables, such as mean age and gender, a Student’s t-test was conducted. For scenarios involving three or more independent continuous or discontinuous variables, such as mean age and type of stimulator, a univariate analysis of variance (one-way ANOVA) was performed. The normal distribution of continuous variables was assessed using the Shapiro-Wilk test. To evaluate significant differences in the frequency distributions of two or more discontinuous variables, the Pearson Chi-square test was utilized. We unified the results of individual charging durations and intervals between recharges and calculated the “charge burden” (the amount of time (min) a patient must invest per week to recharge the device):

Charge Burden (\(\:\frac{min}{week}\)) = \(\:\frac{\text{d}\text{u}\text{r}\text{a}\text{t}\text{i}\text{o}\text{n}\:\text{o}\text{f}\:\text{r}\text{e}\text{c}\text{h}\text{a}\text{r}\text{g}\text{e}\:\left(\text{m}\text{i}\text{n}\right)}{\text{i}\text{n}\text{t}\text{e}\text{r}\text{v}\text{a}\text{l}\:\text{b}\text{e}\text{t}\text{w}\text{e}\text{e}\text{n}\:\text{r}\text{e}\text{c}\text{h}\text{a}\text{r}\text{g}\text{e}\text{s}\:\left(\text{d}\text{a}\text{y}\text{s}\right)\:}\) ∗ 7

The level of significance for all analyses was established at p < 0.05. Confidence intervals were set at 95%. Statistical analysis was conducted utilizing IBM SPSS (IBM Corp., released in 2017). IBM SPSS Statistics for Windows, Version 25.0. (Armonk, NY: IBM Corp.).

2.6. Outcome parameters

Primary objectives

The main objective of this study was to thoroughly assess the process of recharging the system. Patients are requested to evaluate the entire charging process using a semi-quantitative approach, which will provide useful insights into the perceived level of ease or difficulty. In addition, the study aims to measure the proportion of patients who feel confident in working with the system, providing insights into user comfort and confidence levels.

Another important goal was to gather data on the regularity of the recharging process. Patients are required to provide information regarding the frequency of system recharging, the duration of the charging process, their preferred charge level, and their regular activities during this period. Moreover, the study aims to record any complications linked to the devices, allowing patients to identify any obstacles that impede proper recharging. Furthermore, the study examines if an unsuccessful recharging procedure has led to a disruption in therapy due to the battery being completely drained.

Secondary objectives

In addition to the primary objectives, this study investigates the impact of several factors on the primary outcomes. The study will investigate various factors, including patient age, handedness (right or left), experience with the system (time after implantation), kind of pain syndrome, use of opioid-containing analgesics, and the adoption of rechargeable technology. An analysis will be performed on a subset of patients to identify any potential correlations or patterns related to these parameters and the main study goals. This supplementary investigation improves our comprehension of how various patient variables can influence the main results of the study.

2.7. Ethical considerations

The study adhered to the Helsinki Declaration principles. Approval of the study protocol was obtained after a thorough review by the local Ethics Committee. Trial registration: Approval was granted by the Ethics Committee of the Ruprecht-Karls-University Heidelberg (March 20st, 2023 - S-113/2023).

3.1. Study population

A study kit was sent to 13 patients who met the inclusion criteria. Of these, 8 patients (62% return rate) returned the questionnaire along with a signed informed consent form within the stipulated timeframe, rendering them eligible for data analysis. The average age of the participants at the time of the survey was 50.13 ± 7.83 years (ranging from 41 to 61 years). Six (75.0%) patients suffered from chronic painful polyneuropathy, while only 2 (25.0%) patients suffered from complex regional pain syndrome (CRPS) type I. Regarding psychiatric comorbidities, 37.5% of patients disclosed a depression diagnosis, and none reported an anxiety disorder.

The mean duration of pain was 7.56 ± 7.62 years, ranging from 2.5 to 25 years. The mean pain intensity was 3.56 ± 1.95 (with a minimum of 2 and a maximum of 7) on the visual analogue scale (VAS). Regarding the duration of SCS therapy with the CL-SCS, the mean duration was 16.00 ± 8.26 months, ranging from 6 to 30 months. The CL-SCS was implanted in the left gluteal area of 62.5% (n = 5) of the patients and the right gluteal area of 37.5% (n = 3) of the patients (Table 1).

Table 1

Description of studied population
Patients’ characteristics		Number of patients (%), Mean ± SD
Age		50.13 ± 7.827
Gender
	Male	0 (0.0%)
	Female	8 (100.0%)
Diagnosis
	Chronic painful polyneuropathy	6 (75.0%)
	CRPS type I	2 (25.0%)
Handedness	Right	7 (87.5%)
	Left	1 (12.5%)
SCS gluteal implantation site	Right	3 (37.5%)
	Left	5 (62.5%)
Depression		3 (37.5%)
Anxiety disorder		0 (0%)
Duration of pain (years)		7.5 ± 7.6
Pain intensity VAS		3.5 ± 1.9
Duration of therapy (months)		16.0 ± 8.2
Stimulation per day (hours)		24.0 ± 0.0
Opium painkillers		3 (37.5%)
Anti-epileptic medication		4 (50%)
Life With a CL-CSC
User confidence		8 (100%)
How long did it take to feel safe
	1 week	3 (37.5%)
	2 weeks	4 (50.0%)
	4 weeks	1 (12.5%)
Being mobile while charging		5 (62.5%)
Traveled since the operation		5 (62.5%)
Being employed		4 (50%)
Driving by itself		6 (75%)
Use of electronic rechargeable devices		8 (100%)
Recharging
At what intervals do you check the charge level
	Several times a week	1 (12.5%)
	Weekly	4 (50%)
	Every 2 weeks	1 (12.5%)
	Longer	2 (25.0%)
At what intervals do you charge
	Several times a week	3 (37.5%)
	Weekly	3 (37.5%)
	Every 2 weeks	1 (12.5%)
	Longer	1 (12.5%)
At what intervals do you charge the charger
	Weekly	2 (25.0%)
	Every 2 weeks	2 (25.0%)
	Longer	4 (50%)
At which battery level do you charge
	Less than 25%	7 (87.5%)
	Warning alarm	1 (12.5%)
Charging time		107.88 ± 58.018
Being satisfied with charging time		7 (87.5%)
Charging burden
Charging burden (minutes/week)		202.12 ± 222.16
Complications
Understimulation		2 (25.0%)
Overstimulation		1 (12.5%)
Failed charging		1 (12.5%)
Charging interruption		1 (12.5%)

3.2. Life with a CL-SCS device

The mean daily stimulation duration was 24.0 ± 0.0 (SD) hours. 50% (n = 4) of patients checked the battery capacity weekly. 37.5% (n = 3) of patients charged the stimulator daily and 37.5% (n = 3) weekly, while the interchange interval was for more than 4 weeks for 50% (n = 4) of patients. All patients regularly used a rechargeable electronic device such as a smartphone or tablet. 75% (n = 6) of patients drive a car. During the recharging process, the majority of patients, specifically 62.5% (n = 5), didn’t remain stationary. Notably, all of the patients are engaged in life activities such as watching TV, reading, working, cooking due to CL-SCS stimulation. Furthermore, 62.5 (n = 5) patients had undertaken travel since the implantation of the CL-SCS system. The median rating of the statement “Wearing the stimulator reminds me of my disease” was "disagree". Only one patient reported this as an “agreement” and 1 patient as a “complete agreement". N = 4 patients completely agreed with the statement “wearing of CL-SCS is an active participation in own treatment." All the patients completely disagreed with the allegation of “fear of forgetting to recharge".

3.3. Recharging process

The overall convenience of recharging and the burden of using the CL-SCS were rated as "easy" and "low" with a median score of 10.0 points. 50% (n = 4) of patients checked the CL-SCS device battery status weekly. This checking interval varied from mostly weekly to every 14 days for the remaining patients (n = 4). A total of 87.5% (n = 7) of patients opted to charge the stimulator when the remaining battery level was below 25%. Another 12.5% (n = 1) chose to recharge when a warning was issued. CL-SCS charging took 107.88 ± 58.01 minutes (range 45 to210 minutes). On average, patients rated the convenience of establishing the connection between the transmitter and implanted receiver during stimulation as "neutral." The overall handling and CL-SCS utilization were rated as "easy". According to patients' expectations, non-rechargeable stimulators should last for a mean time of 7.50 ± 2.33 years (range 5 to 10 years) to be considered as a viable alternative to r-IPGs.

3.4. Charge burden

The mean charge burden was 202.12 ± 222.16 min/week (range 30 to 639 min/week), with a median of 97.50 min/week required to recharge the device. There were no significant differences among the subgroups (age groups, gender, pain location, type of neurostimulator, or stimulator position) regarding charge burden. The duration of time patients had been treated with a CL-SCS was significantly associated with higher charge burden (p = 0.03).

The associated factors (working, driving, use of rechargeable devices, opioid medication) did not have any significant impact on the charge burden either. However, there was a significant, strong positive association between battery consumption and charge burden (p = 0.035).

3.5. User confidence and user satisfaction

All 8 patients felt confident handling, monitoring, and recharging the device. Among the patients, 37.5% (n = 3) took one week to feel confident. 50% (n = 4) were confident after two weeks. And 12.5% (n = 1) were confident after four weeks. In 62.5% (n = 5) of patients, a single training session with the device was sufficient to feel confident using the device. All patients felt adequately prepared to use the CL-SCS device after the final training session. With a mean of 63.13 ± 40.79, they agreed that the recharge time enabled them to actively participate in their therapy. All patients would recommend a rechargeable system to another patient. All of them would choose the CL-SCS device again.

3.6. Device‑related satisfaction

While the implant volume of r-CL-IPGs is smaller compared to non-rechargeable ones, the implant can still cause cosmetic issues. While most patients rated the size very small (50%), twice as many patients (25%) regarded the device as neutral, rather than big (12.5%) or very big (12.5%).

3.7. Complications

12.5% (n = 1) of patients reported problems with recharging, which resulted in stimulation interruption in 12.5% (n = 1) of patients. In 12.5% (n = 1) of cases, recharging system parts had to be replaced. All patients reported a very low level of fear of forgetting to recharge.

No significant differences in the rate of complications were detected for any of the subgroups (age, gender, pain location, position of the neurostimulator, the time of implantation, and opioid use) or associated factors (pursuing a job, driving, and use of rechargeable devices).

The Recharge Pain Trial is the first, patient-centric study of chronic and neuropathic pain patients treated with CL-SCS devices and provides valuable insight into the experience of chronic pain patients utilizing CL-SCS devices, focusing on the convenience and user satisfaction of the recharging process. The study's primary objective was to assess various aspects of the recharging process, including patient confidence, charge burden, and complications. The results shed light on both the benefits and limitations of CL-SCS devices.

Patient Experience and Recharging Convenience

The findings from our study highlight that patients, on average, rated the overall handling of recharging as "very easy," indicating a high degree of user-friendliness associated with the CL-SCS system. This positive response underscores efforts aimed at enhancing the overall patient experience with SCS technology. Comparatively, a previous study examining OL-SCS therapy revealed a similar trend, with patients generally perceiving the recharging process as "easy". However, issues such as failed recharges and interruptions of stimulation were still reported, suggesting that despite advancements, there remain challenges to address in optimizing the reliability and effectiveness of SCS systems 12. The CL-SCS devices, on the other hand, were found to be superior in terms of convenience, safety, and patient satisfaction. The evidence from previous studies, particularly the research conducted by Mekhail et al., consistently underscores the superior and clinically significant pain relief achieved with closed-loop devices, particularly within a 12-month timeframe, in comparison to traditional OL-SCS methods 10. These findings emphasize the dual benefits of user confidence and enhanced pain relief associated with closed-loop technology in the management of chronic pain. Moreover, our study contributes to this understanding by revealing insights into the use of opium analgesics among patients. It was found that a notable percentage of patients were utilizing opium analgesics for pain management. However, studies have demonstrated that CL-SCS therapy can significantly reduce or even eliminate the need for opioids in a remarkable 82.8% of patients who were initially using these pain medications 9. This highlights the potential of CL-SCS technology not only in providing effective pain relief but also in mitigating the reliance on opioid medications, thereby addressing concerns related to opioid dependence and misuse in chronic pain management.

Recharging Frequency and Duration

The study delved into the specifics of the recharging process, including frequency, duration, and patient preferences. Noteworthy findings include the majority of patients checking the battery status weekly, with a significant portion choosing to recharge when the battery level dropped below 25%. This finding aligns with previous studies demonstrating a link between battery capacity being less than 25% and increased therapy interruptions 12. While our study did not find a statistically significant correlation between battery level and therapy interruptions, the potential association remains worthy of further investigation. Additionally, the mean duration of recharging, offers valuable insights into the time commitment necessary for maintaining CL-SCS devices.

Integration into Daily Life and Patient Adherence

While CL-SCS demands a greater level of user engagement compared to traditional rechargeable OL-SCS devices, the study underscores the positive impact on patients' lives 12. Most patients did not remain stationary during the recharging process, engaging in various daily activities such as watching TV, reading, working, and cooking. This suggests that CL-SCS integrates well into patients' lifestyles, potentially contributing to increased adherence to therapy.

Long-Term Considerations and Charge Burden

However, the convenience of recharging was rated positively, the study acknowledges that CL-SCS requires a greater level of user engagement compared to rechargeable OL-SCS devices 12. The OL-SCS system is a type of medical device that requires patients to charge it for a certain amount of time each week. The exact amount of time can vary depending on the individual patient's needs. While it is important for patients to be able to manage their medical devices, it is also important that they do not find this to be too time-consuming or burdensome. Although, our study showed the mean charge burden indicates a considerable time commitment, it is generally manageable for most patients. Furthermore, upon completion of the study, we observed that the information provided by the patients in the questionnaires did not always align with the actual charge and charging time, which can be retrospectively discerned quite well from the CL-SCS systems. This discrepancy was noted in one patient who was unable to manage the system. Importantly, the study revealed a significant association between the duration of time patients had been treated with CL-SCS and the charge burden, highlighting the importance of long-term considerations in the implementation of such devices. A recent study conducted by Duarte et al., aimed to assess the cost-effectiveness of CL-SCS compared to rechargeable OL-SCS for managing chronic back and leg pain. The study indicates that CL-SCS not only surpasses OL-SCS in terms of efficacy but also proves to be cost-effective, demonstrating dominance around five years post-implantation 13. Closed-loop systems, by continuously adapting to the patient's physiological feedback, offer a more sophisticated and personalized approach compared to open-loop systems. The positive economic findings for CL-SCS emphasize the potential advantages of closed-loop technology in the long-term management of chronic pain 13.

Patient Satisfaction, Cosmetic Concerns, and Complications

Patients expressed overall satisfaction with the CL-SCS device, with minimal cosmetic concerns related to the implant. The reported complications, such as failed recharge and interruption in stimulation therapy (both at 12.5%), were notably lower than those observed in older studies on OL-SCS. This suggests that CL-SCS technology has made substantial improvements, addressing issues related to recharging and interruption, thus enhancing the reliability of the therapy. Our closed-loop system had significantly lower rates of failed recharges and interruptions of stimulation compared to the open-loop study, indicating that closed-loop technology can improve the reliability and user satisfaction of r-IPGs for SCS 12.

Fear of Forgetting to Recharge and Patient Acceptance

The study identified a very low level of fear among patients regarding forgetting to recharge, suggesting that the CL-SCS system has become an integrated and accepted part of their daily lives. This finding highlights the importance of patient education and device design in promoting user confidence and long-term adherence.

The main limitations of our study include a small sample size, single-center results, and short-term follow-up. As this innovation is quite new, we will address these uncertainties in the future with more patients and prospective studies. The lack of return of questionnaires (only 62% of the sent questionnaires), is not unusual for this type of study, and incomplete questionnaires result in a gap in the data, which negatively affects the validity of the data. All of which limits the generalizability of the presented findings. Also, the decision to implant a CL-SCS was based on patient preference and physician recommendation, not any standardized approach. Also, a prospective and randomized study with equal and large sample sizes is required to find out whether user satisfaction and impact on QOL differ between OL-SCS and CL-SCS systems or between different CL-SCS models.

Our findings from chronic pain patients using CL-SCS demonstrate promising results, highlighting increased patient confidence and comfort. While CL-SCS requires a greater level of user engagement than traditional devices, the observed benefits, including reduced recharging and fewer interruptions, make it a compelling alternative. These preliminary insights underscore the need for comprehensive and extensive comparative studies with conventional SCS devices. Given the favorable outcomes reported from the patient's perspective and the technical advancements associated with CL-SCS systems, we are encouraged to support the continued preference for the implantation of rechargeable IPGs over non-rechargeable alternatives.

r-IPGs: rechargeable implantable generators

SCS: spinal cord stimulation

CL-SCS: closed-loop SCS

ECAP: evoked compound action potential

ECAPs: evoked compound action potentials

SD: standard deviation

OL-SCS: open-loop spinal cord stimulation

QOL: quality of life

CRPS: complex regional pain syndrome

VAS: visual analogue scale

Acknowledgements Not applicable

Authors' contributions Mohammad Mehdi Hajiabadi: Investigation, Data analysis, Conceptualization, Data curation, Methodology; Adrina Habibzadeh: Writing – Original Draft, Visualization, Writing – Review & Editing; Martin Jakobs: Software, Validation, Formal analysis, Writing – Review & Editing; Sandro Krieg: Supervision, Project administration, Writing – Review & Editing; Rezvan Ahmadi: Supervision, Project administration, Resources, Investigation, Methodology, Writing – Review & Editing

Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests All authors declare they have no financial interests.

Funding The first author, Mohammad Mehdi Hajiabadi, has received consultation fees by Saluda Medical. No industrial sponsorship was involved in the creation or execution of this study.

Ethics approval This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Ruprecht-Karls-University Heidelberg (March 20st, 2023 - S-113/2023).

Consent to participate Informed consent was obtained from all individual participants included in the study.

Consent to publish This manuscript does not include any individual person’s data such as individual details, images or videos. Therefore, separate consent was not necessary. All participants were informed in the informed consent process that the data collected in this study was meant to be published.

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No competing interests reported.

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Evaluating Comfort and Efficacy: A Comprehensive Analysis of ECAP-Controlled Closed-Loop Spinal Cord Stimulation from Patient Perspectives

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Version 1

Abstract

1. Background

2. Methods

2.1. Trial

2.2. Patients

2.3. Design and procedure

2.4. Questionnaire design

2.5. Statistical analysis

2.6. Outcome parameters

2.7. Ethical considerations

3. Results

3.1. Study population

3.2. Life with a CL-SCS device

3.3. Recharging process

3.4. Charge burden

3.5. User confidence and user satisfaction

3.6. Device‑related satisfaction

3.7. Complications

4. Discussion

5. Limitations

6. Conclusion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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