Preventing Sudden Cessation of Implantable Pulse Generators in Deep Brain Stimulation: A Systematic Review and Protocol Proposal Free

Deep brain stimulation (DBS) is an FDA-approved therapeutic modality for various neurological and psychological disorders. DBS has shown significant improvements in patients’ disease symptoms and quality of life [1]. However, the success of DBS therapy depends on the continuous availability of electrical power to deliver adequate therapy from the implantable pulse generator (IPG). Unfortunately, patients and physicians may not be aware of the power status of the IPG, which puts patients at risk of sudden therapy drop-off or cessation. This can result in complications such as severe rebound tremor, catatonia, pain, and, in rare cases, death [2, 3].

One of the first solutions devised for preventing the end-of-service (EOS) of non-rechargeable IPGs was the rechargeable IPG. However, while recharging is generally considered simple and straightforward, these devices may not be suitable for all patients, such as those with limited social support, advanced age, and cognitive issues [4]. Previous studies have also shown that patients frequently prefer non-rechargeable IPGs, reporting that charging their devices feels restrictive [5, 6].

Despite recent strides in DBS IPG battery technology [7], inadvertent cessation of therapy from DBS IPG EOS remains a key issue. This review seeks to explore protocols for postoperative management of fixed-life IPGs in North American healthcare centers. It aimed to assess current literature on DBS IPG battery life management and proposes a protocol for healthcare providers.

This literature review followed the PRISMA 2020 statement (https://doi.org/10.1136/bmj.n71) for systematic reviews and meta-analyses. A thorough search for North American healthcare system protocols, encompassing diverse study designs, focused on English publications from 2012 to the present. Exclusions included animal studies and those unrelated to postoperative IPG battery life management. MEDLINE, CINAHL Complete, SCOPUS, and EBSCOhost databases were systematically searched using defined keywords. Gray literature, or unpublished but publicly available literature, was examined for completeness. The University of Oklahoma Health Sciences Center Bird Library librarian collaborated to ensure accuracy. Two independent reviewers (S.J.O. and H.H.S.) screened results based on pre-defined criteria, with disagreements resolved through discussion or senior review (A.K.C.). Selected full texts explicitly discussing IPG life management protocols were included. Data extraction covered author details, study design, outlined guidelines, and internal protocol assessment. Guidelines were categorized as qualitative, quantitative, or both for simplification, and an outline of the literature review was created following the PRISMA flowchart guidelines (Fig. 1).

We crafted a protocol for non-rechargeable IPG management based on patient concerns during DBS implantation and literature on device management in similar contexts. Input was gathered from the patient's care team, including movement disorder neurologists and IPG manufacturers. We plan to implement this protocol fully after creating the required patient educational resources and communicating institutional changes to collaborating neurologists and device representatives.

Of the 408 citations screened, seven met inclusion criteria and were reviewed (Table 1). Out of all included studies, five studies attempted to outline a qualitative narrative guideline for managing IPG battery longevity. One attempted to create a web-based quantitative calculator to estimate the battery life of IPGs. Moreover, another presented both a qualitative and quantitative guidance method. Another evaluated their presented protocols in comparison to estimators from IPG manufacturers with statistical analysis.

We propose a novel DBS protocol (Fig. 2) based on input from our neurology colleagues, DBS manufacturers and patients, and the findings from our literature review. Our protocol can be divided into preoperative and postoperative implementation stages.

In the preoperative stage, collaboration among neurology, neurosurgery, and the IPG manufacturer is for determining the appropriate IPG and DBS target. Patients are informed and encouraged to use rechargeable IPGs when possible. For patients opting for a fixed-life IPG based on their circumstances, comprehensive preoperative education is provided a week before surgery.

In the postoperative stage, educational content from the preoperative phase is reintroduced 2 weeks postoperatively, including hands-on training with the patient’s device. This session reviews and reinforces preoperative education, demonstrating practical application. Patients receive guidance on contacting their neurosurgeon for IPG replacement and managing the IPG reaching EOS. Scheduled follow-ups are crucial for long-term care. Initial neurosurgical follow-ups occur at 2 weeks, assessing healing and DBS management understanding. Subsequent 1-year follow-ups monitor device experience, IPG status, and patient understanding. Neurology follow-ups every 3–6 months post-surgery focus on device programming, symptom control, and patient comfort, with intervals adjusted based on mutual discretion and progress.

We reviewed the current literature on DBS IPG management, exploring techniques and technologies to prevent IPG cessation. While some papers proposed protocols for IPGs nearing EOS, none offered a comprehensive approach to prevent therapy cessation.

Telemedicine is a promising avenue for Parkinson’s management, enabling remote assessments, monitoring, and therapy adjustments. Fasano et al. highlighted its role as a screening tool for replacing DBS IPGs [9]. Despite potential challenges in virtual evaluations due to the condition's intricacy and technological proficiency gaps in patients, remote assessments offer valuable insights. Expanding on this, Frey et al. explore the benefits of telemedicine and remote programming for IPG management [14]. They emphasize remotely adjusting DBS settings to reduce the need for frequent in-person visits, minimizing patient burden and healthcare costs. Telemedicine emerges as a valuable tool in preventing DBS therapy cessation, especially for patients in remote areas.

Automated DBS devices, explored by Frey et al., use advanced technology to assess patients’ needs and adjust stimulation settings in real-time [14]. These devices, employing sophisticated algorithms and feedback mechanisms, continuously monitor symptoms, offering precise and adaptive therapy. While promising, their real-world application for DBS remains limited. Education for patients and providers is crucial to maximize effectiveness in the current gap in DBS device monitoring.

Calculators, like Montuno et al.’s, estimate IPG battery life and aid device management [11]. However, accurate prediction remains challenging due to factors such as impedance fluctuations, battery usage patterns, and device variation. While these calculators signify progress, establishing their reliability as the standard in IPG management requires further clinical evidence. Fakhar et al. [15] compared various IPG calculators, including Medtronic and Montuno et al.’s. They recommended using these calculators, especially with worsening symptoms, to predict IPG battery life and optimize treatment planning.

Several papers propose DBS IPG management protocols for EOS scenarios. Miocinovic et al. introduced a flowchart algorithm for prompt replacement in cases of sudden DBS cessation, preventing severe consequences like Tourette syndrome and severe depression [10]. Montuno et al. [11] presented an online calculator with a flowchart for patient concerns. However, all mentioned protocols focus solely on scenarios after EOS of therapy cessation.

Non-rechargeable power sources are extensively employed in various medical applications, including pacemakers, defibrillators, and pain pumps. Strategies proven effective in managing these devices can be adapted for DBS IPG management. Innovative solutions, such as leveraging mobile cell phone technologies, are employed in other medical devices for patient-reported blood pressure checks, appointment reminders, pre-surgery education, and medication reminders [8, 16, 17].

Research findings indicate increased patient satisfaction with mobile technologies and willingness for future use [18, 19]. Communication through email studies/surveys [20] and telehealth visits [21] has shown high levels of patient satisfaction and adherence to home treatment options.

Pacemakers, functioning similarly to DBS systems, encounter issues like premature battery depletion and maladaptive symptoms [22‒24]. Cardiologists advocate preventive measures, including patient education and comprehensive outpatient follow-up. The Abbott Neurosphere offers a notable future solution with its similarity to the remote pacemaker monitoring system, merlin.net [25].

Cochlear implants share similarities with DBS, requiring timely power source management. Cochlear implant clinicians and patients extensively utilize telehealth checkups, resulting in empowerment and improved hearing outcomes [26‒28] similar to DBS.

Abrupt drug delivery cessation in implantable drug delivery systems, like intrathecal pumps, due to battery depletion could be life-threatening [29, 30]. Vigilant follow-up through in-person checkups, video conferences, email, and text messages is utilized to prevent therapy cessation risk [31‒33]. Regardless of the technology used, patient education and regularly scheduled outpatient follow-ups remain a common theme for monitoring device status.

In the preoperative stage, patient education is pivotal in our protocol, aiming to empower patients and families with essential knowledge for informed decision-making and effective management of DBS devices. One week before surgery, patients receive a tailored education package, including a manufacturer-specific handout and an institutional educational video. These materials cover crucial topics such as checking the IPG battery, self-monitoring for therapy disruption symptoms, anticipating IPG depletion, understanding the expected timing for personal device replacement, and ensuring comprehensive pre-surgery information.

DBS education, both preoperative and postoperative, presents a critical and complex challenge. For preoperative education, we advocate a multidisciplinary approach involving movement disorder neurologists and the DBS implanting neurosurgeon. Both provide in-depth education, fostering repetition and reinforcement. In the postoperative stage, nursing staff or other skilled providers can delegate hands-on assessment of patient understanding of their IPG device and interrogator, offering specialized guidance and tailored training for the specific device.

Integral to our protocol is an educational video covering IPG battery checks, self-monitoring for therapy disruption symptoms, anticipating IPG depletion, and understanding expected timing for personal device replacement. This video facilitates patient review of crucial DBS IPG maintenance information, providing answers to questions at their convenience. This approach enhances efficiency, minimizes mismanagement risks, and ensures accessible knowledge for patients and caregivers.

The reviewed studies demonstrate promise but acknowledge potential biases and limitations, primarily falling into Category 5 (grade D) with low internal validity. This implies potential bias in current IPG management strategies and the selected studies. Our systematic literature review is constrained by reliance on studies with low evidence levels, potentially introducing bias. Like all reviews, it may be susceptible to internal biases, and the limited sample size of 7 articles restricts comprehensive conclusions. Despite these constraints, the identified papers offer valuable insights for future IPG management research. Our DBS IPG management protocol relies on experiences from analogous devices and involves multiple providers. Maintaining communication is crucial. This novel protocol lacks prior experience, but we aim to refine it post-implementation.

The current literature on DBS IPG management lacks high-quality studies, emphasizing the need for more rigorous research to optimize patient outcomes. To bridge this gap, we propose a comprehensive protocol that prioritizes standardized patient education, regular follow-up care, and thorough preoperative and postoperative IPG battery monitoring. Our goal is to empower patients for independent DBS IPG monitoring, supported by consistent clinician oversight. As DBS IPG technologies advance, we aim to refine and integrate improvements into future protocol iterations.

We thank Tressie M. Stephens for her administrative assistance with coordinating the research and submission of this work.

This study is based on published literature and was reviewed and approved by the University of Oklahoma Institutional Review Board, approval number [14696].

The authors declare that they have no conflict of interest.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data collection and interpretation: S.J.O. and H.S.S. Idea conception and design: A.K.C., S.J.O., and H.S.S. Drafting of the original manuscript: S.J.O. Edits: H.S.S. and A.K.C.

All data generated or analyzed during this study are included in this published article. Further inquiries can be directed to the corresponding author.