Chinese guidelines on remote programming of deep brain stimulation for patients with Parkinson’s disease

Deep brain stimulation (DBS) is a neurosurgical procedure that allows targeted circuit-based neuromodulation; it is also a standard of care for Parkinson’s disease (PD).[1] Postoperative DBS programming is a crucial step that can specify the best stimulation parameters and release symptoms to promote patients’ quality of life. The “Chinese Expert Consensus on Programming Deep Brain Stimulation for Patients with Parkinson’s Disease”, which was published in 2016, regulated the application of postoperative programming for PD patients.[2] However, multiple aspects limited patients’ ability to attend face-to-face programming, including their mobility and the geological distance between their residences and the DBS center, which led to a higher rate of patients using remote programming with increasing frequency, making it an urgent demand.[3,4] Therefore, it is important to create a standard protocol to guide the application of this remote treatment. Remote programming refers to the process by which doctors connect DBS equipment via the internet and program the parameters remotely. It could overcome residential distance and reduce travel costs, offering convenience for patients and doctors.[5–7] It has been found that remote programming has treatment effects that are equivalent to those of face-to-face programming.[8] However, as an emerging technology, remote programming in China is currently limited to relatively larger DBS centers, and standardization is required to generalize its application so that more patients can benefit from it. Therefore, we propose this guideline to summarize the recent outcomes of postoperative remote programming studies for PD patients. Introduction to remote DBS programming: Remote programming relies on the development of DBS hardware, software, and communication technology. It usually includes a remote program for doctors and a remote program for patients. The remote program for doctors refers to the clinician programming system on the doctor’s computer. The remote program for patients is a combination of the patient programmer and the smartphone with mobile software or the smart terminal and a monitor. Patients can communicate with their doctors via video calls, using their smartphones, or the camera on the smart terminal. Doctors can program or adjust the stimulation parameters of the implantable pulse generator (IPG) remotely after the IPG is connected to the patient programmer or the smart terminal. Remote programming can be operated by medical personnel or healthcare providers in local medical centers or personally by patients and their caretakers [Supplementary Figure 1, https://links.lww.com/CM9/C227]. Clinicians in local hospitals or clinics can submit remote programming requests to the professional PD center for patients and assist with the process while DBS programming is performed remotely. It is relatively safe, as the programming is processed in the presence of a doctor, but it also requires the patient to attend the facility in person and is affected by geological distance. Face-to-face programming means that the PD patients have to travel certain distance from home to hospitals or clinics with financial cost for each follow-up. The PD centers can also perform remote programming directly for the patient with the company of their caretakers, which is more convenient. However, if patients have delayed adverse reactions and the caretakers cannot provide adequate treatment, adverse events can occur. Suitable and unsuitable conditions for remote DBS programming for patients with PD Indication for remote programming: Remote programming is recommended for patients who live in remote areas and have higher travel costs. The Internet is not limited by geological distance. China has a vast territory, which makes it more necessary for PD patients with DBS to be remote. Hence, patients who live in remote areas can enjoy standardized professional postoperative programming.[3] Patients with limited mobility are also suitable for remote programming. Assisting mobility-impaired patients requires more than one caretaker. Face-to-face programming would increase the travel and accommodation costs for the family compared to remote programming. For patients whose condition is relatively stable and requires only simple parameter adjustments, stimulation performance tests, or maintenance in their follow-ups, remote programming would also be a serviceable and more convenient option with a high degree of satisfaction. Contraindications for remote programming: Remote programming is not suitable when the patient is short of caretakers. During the programming, the patient may not be able to cooperate due to unexpected adverse reactions; hence, external assistance is required. PD patients are also recommended face-to-face programming for their first initiation, which needs to test the therapeutic window and adjust different stimulation parameters. Patients without experience or knowledge of programming may feel worried. Face-to-face programming provides better comfort for patients. For patients with complicated conditions or for whom cooperation is difficult, simple parameter adjustments cannot promote treatment outcomes. Furthermore, clinicians cannot assess patients’ physical condition directly via remote programming; hence, symptoms such as rigidity are difficult to detect. Face-to-face programming is recommended for these patients to achieve better treatment outcomes. Additionally, patients showing severe anxiety or depression often have more requirements; thus, face-to-face programming is recommended for them, if it can better serve their interests. Paradigm for remote DBS programming Training patients and caretakers: Patients and their caretakers should be trained to master the hardware and software before the remote programming procedure. Only patients and caretakers who pass the training should be considered for remote programming. Procedure for remote programming: The general process of remote programming is displayed in Supplementary Figure 2, https://links.lww.com/CM9/C227. A programming clinician can use “the remote program for doctor” software (on a computer or smartphone) to schedule appointments and open reservations. Patients and their caretakers can log in to “the remote program for patient” software on smartphones or smart terminals at the same time. Patients can then sign the remote programming contract, fill in patient’s information (including demographics, the main complaint for the current session, medical history, and current medication status), and make a remote programming appointment. According to personal needs, patients can also fill in “PD notes” and self-rating scales or upload head computed tomography (CT)/magnetic resonance imaging (MRI) images and patient videos to the software. Clinicians can view these documents, check programming histories on their platform, and approve patients’ remote programming applications. Patients or caretakers can log in to the software as scheduled, bind the patient programmer, test the connection with the IPG, and submit a remote programming request, or the patient could open the smart terminal and wait for their remote consultation. Programming clinicians should log in to the “remote program for doctors” software, use audio and video calls to communicate with a patient and caretakers, understand the patient’s condition, evaluate the patient’s mobility, and record the patient’s performance according to their motor dysfunction condition. During remote programming, the clinician tests the impedance and battery voltage, adjusts stimulation parameters (including amplitude, pulse width, frequency, contact configuration, current mode, voltage mode, etc.), and observes treatment effects. Programming clinicians should compare and analyze a patient’s programming history, videos that record symptoms, image data, and so on to generate therapeutic parameters for the current session. The system generates remote programming logs and saves relevant medical documents for the patient and the clinician to access using their terminal after the procedure. Initiation and follow-up of remote programming: Remote programming initiation and follow-up visits should proceed according to expert consensus.[2] Face-to-face consultation is recommended for the first initiation. If there are difficulties for patients to attend in person, remote programming as an alternative is needed to secure the patients and prevent them from falling during off-medication symptom evaluations. Clinicians are suggested to consult postoperative image data that shows the location of the electrodes. Parameter settings, modulation, and medication adjustments can be performed according to relevant Chinese expert consensus on DBS for patients with PD.[2] Safety of remote programming: When the Internet is unstable or cut off completely, patients should be able to reset the parameters to previous settings. Remote programming requires an adequate parameter-recovering function to restore the stimulation parameters of the IPG to the previous setting without the Internet when experiencing disturbances. Before remote programming, clinicians should notify patients about detailed procedures and any potential risks, secure their personal information and medical data, and fully respect their privacy rights. Remote programming also requires a complete identity verification system to ensure that patients are directed to the right clinician. The system should also prevent unscheduled visits from any unexpected third party. Remote programming platforms need to record every detail of every remote programming session. Every record needs to align with relevant laws and professional standards to ensure that the data are complete and secure. The informed consent and relevant contract signed by the patient and doctor, acknowledgment of rights and risks, and the development of the information system should not violate the requirements of level-three information security. Limitations of remote programming: Remote programming is a newly developed treatment that still needs improvement. Its treatment effects are affected by the educational background, cognitive ability, and cooperation willingness of patients and their caretakers. Using video communication on an online platform also ties the Internet condition to the performance of remote programming. Remote consultation also restricts the clinician’s ability to perform a full physical examination, which may challenge their understanding of a patient’s condition. Currently, remote programming cannot completely replace face-to-face programming. Clinicians and patients should hold reasonable expectations. Cautions of remote programming: Remote programming is helpful and supplementary to face-to-face programming. Patients and caretakers need to have adequate knowledge of the effects and risks of remote programming, and they can cooperate with clinicians. Clinicians need a sufficient understanding of PD patients’ operation history, current medication status, complaints, and the results of remote programming to fulfill their requirements. During remote programming, patients should be accompanied by caretakers who can operate their programs and handle adverse reactions properly by reducing the stimulation voltage or shutting down the IPG in time. Caution is needed when widely adjusting the parameters. Opening or adjusting the access of patient programmer should be within the safety range. According to a patient’s symptoms, the patient or the caretaker can make programming adjustments and reset to the original parameters when needed. Remote programming has irreplaceable advantages over traditional face-to-face programming. It has become increasingly important in postoperative DBS programming with wide application prospects. The legal and regulatory aspects of remote programming, such as patient consent, data security, and compliance, should be further refined to address any ethical and legal concerns. Remote programming can be safely and positively applied according to patients’ conditions in clinical practice, helping to serve an increasing number of patients with PD. Members of the guideline advisory panel are shown in Supplement Materials, https://links.lww.com/CM9/C227. Funding This work was supported by grants from the National Key Research and Development Program of China (Nos. 2022YFC2405100 and 2021YFC2401200), the National Natural Science Foundation of China (No. 81830033), the Key R&D Program of Jiangsu Science and Technology Project (No. BE2022049), and the Key Research and Development Program of Henan Province (No. 241111310100). Conflicts of interest None.