prototype of the at-home multi-modal data collection platform for adaptive deep brain stimulation

Optimizing Deep Brain Stimulation for Patients with Neurological Disorders

Deep brain stimulation (DBS) treats neurological disorders such as Parkinson&#39;s disease (PD) by delivering electrical current directly to specific regions in the brain. There are an estimated 8.5 million cases of PD worldwide, and DBS has proved to be a critical therapy when medication is insufficient for managing symptoms1,2. However, DBS effectiveness can be constrained by side-effects that sometimes occur from stimulation that is conventionally delivered at fixed amplitude, frequency, and pulse width3. This open-loop implementation is not responsive to fluctuations in symptom state, resulting in stimulation settings that are not appropriately matched to the changing needs of the patient. DBS is further hindered by the time-consuming process of tuning stimulation parameters, which is currently performed manually by clinicians for each individual patient.
Adaptive DBS (aDBS) is a closed-loop approach shown to be an effective next iteration of DBS by adjusting stimulation parameters in real time whenever symptom-related biomarkers are detected3,4,5. Studies have shown beta oscillations (10-30 Hz) in the subthalamic nucleus (STN) occur consistently during bradykinesia, a slowing of movement that is characteristic of PD6,7. Similarly, high-gamma oscillations (50-120 Hz) in the cortex are known to occur during periods of dyskinesia, an excessive and involuntary movement also commonly seen in PD8. Recent work has successfully administered aDBS outside the clinic for prolonged periods5, however the long-term effectiveness of aDBS algorithms that were configured in-clinic while a patient is home has not been established.
Remote systems are needed to capture the time-varying effectiveness of these dynamic algorithms in suppressing symptoms encountered during daily living. While the dynamic stimulation approach of aDBS potentially enables a more precise treatment with reduced side-effects3,9, aDBS still suffers from a high burden on clinicians to manually identify stimulation parameters for each patient. In addition to the already large set of parameters to program during conventional DBS, aDBS algorithms introduce many new parameters which must also be carefully adjusted. This combination of stimulation and algorithm parameters yields a vast parameter space with an unmanageable number of possible combinations, prohibiting aDBS from scaling to many patients10. Even in research settings, the additional time required to configure and assess aDBS systems make it difficult to adequately optimize algorithms solely in the clinic, and remote updating of parameters is needed. To make aDBS a treatment that can scale, stimulation and algorithm parameter tuning must be automated. In addition, outcomes from therapy must be analyzed across repeated trials to establish aDBS as a viable long-term treatment outside the clinic. There is a need for a platform that can collect data for remote evaluation of therapy effectiveness, and to remotely deploy updates to aDBS algorithm parameters.
The goal of this protocol is to provide a reusable design for a multi-modal at-home data collection platform to improve aDBS effectiveness outside the clinic, and to enable this treatment to scale to a greater number of individuals. To our knowledge, it is the first data collection platform design that remotely evaluates therapeutic outcomes using in-home video cameras, wearable sensors, chronic neural signal recording, and patient-driven feedback to evaluate aDBS systems during controlled tasks and naturalistic behavior.
The platform is an ecosystem of hardware and software components built upon previously developed systems5. It is maintainable entirely through remote access after an initial installation of minimal hardware to allow multi-modal data collection from a person in the comfort of their home. A key component is the implantable neurostimulation system (INS)11 which senses neural activity and delivers stimulation to the STN, and records acceleration from chest implants. For the implant used in the initial deployment, neural activity is recorded from bilateral leads implanted in the STN and from electrocorticography electrodes implanted over the motor cortex. A video recording system helps clinicians monitor symptom severity and therapy effectiveness, which includes a graphical user interface (GUI) to allow easy cancellation of ongoing recordings to protect patient privacy. Videos are processed to extract kinematic trajectories of position in two dimensional (2D) or three dimensional (3D), and smart watches are worn on both wrists to capture angular velocity and acceleration information. Importantly, all data is encrypted before being transferred to long-term cloud storage, and the computer with patient-identifiable videos can only be accessed through a virtual private network (VPN). The system includes two approaches for post-hoc time-aligning of all data streams, and data is used to remotely monitor the patient&#39;s quality of movement, and to identify symptom-related biomarkers for refining aDBS algorithms. The video portion of this work shows the data collection process and animations of kinematic trajectories extracted from collected videos.
A number of design considerations guided the development of the protocol: 
Ensuring data security and patient privacy: Collecting identifiable patient data requires utmost care in transmission and storage in order to be health insurance portability and accountability act (HIPAA)12, 13 compliant and to respect the patient&#39;s privacy in their own home. In this project, this was achieved by setting up a custom VPN to ensure privacy of all sensitive traffic between system computers. 
Stimulation parameter safety boundaries: It is critical to ensure that the patient remains safe while trying out aDBS algorithms that may have unintended effects. The patient&#39;s INS must be configured by a clinician to have safe boundaries for stimulation parameters that do not allow for unsafe effects from over-stimulation or under-stimulation. With the INS system11 used in this study, this feature is enabled by a clinician programmer. 
Ensuring the patient veto: Even within safe parameter limits, the daily variability of symptoms and stimulation responses may result in unpleasant situations for the patient where they dislike an algorithm under test and wish to return to normal clinical open-loop DBS. The selected INS system includes a patient telemetry module (PTM) that allows the patient to manually change their stimulation group and stimulation amplitude in mA. There is also an INS-connected research application that is used for remote configuration of the INS prior to data collection14, which also enables the patient to abort aDBS trials and control their therapy. 
Capturing complex and natural behavior: Video data was incorporated in the platform to enable clinicians to remotely monitor therapy effectiveness, and to extract kinematic trajectories from pose estimates for use in research analyses15. While wearable sensors are less intrusive, it is difficult to capture the full dynamic range of motion of an entire body using wearable systems alone. Videos enable the simultaneous recording of the patient&#39;s full range of motion and their symptoms over time. 
System usability for patients: Collecting at-home multi-modal data requires multiple devices to be installed and utilized in a patient&#39;s home, which could become burdensome for patients to navigate. To make the system easy to use while ensuring patient control, only the devices that are implanted or physically attached to the patient (in this case it included the INS system and smart watches) must be manually turned ON prior to initiating a recording. For devices that are separate from the patient (in this case it includes data recorded from video cameras), recordings start and end automatically without requiring any patient interaction. Care was taken during GUI design to minimize the number of buttons and to avoid deep menu trees so that interactions were simple. After all devices are installed, a research coordinator showed the patient how to interact with all devices through patient-facing GUIs that are a part of each device, such as how to terminate recordings on any device and how to enter their medication history and symptom reports. 
Data collection transparency: Clearly indicating when cameras are turned ON is imperative so that people know when they are being recorded and can suspend recording if they need a moment of privacy. To achieve this, a camera-system application is used to control video recordings with a patient-facing GUI. The GUI automatically opens when the application is started and lists the time and date of the next scheduled recording. When a recording is ongoing, a message states when the recording is scheduled to end. In the center of the GUI, a large image of a red light is displayed. The image shows the light being brightly lit whenever a recording is ongoing, and changes to a non-lit image when recordings are OFF.
The protocol details methods for designing, building, and deploying an at-home data collection platform, for quality-checking the data collected for completeness and robustness, and for post-processing data for use in future research.
<img alt="Figure 1" class="xfigimg" src="/files/ftp_upload/65305/65305fig01.jpg" /> 
Figure 1: Data flow. Data for each modality is collected independently from the patient&#39;s residence before being processed and aggregated into a single remote storage endpoint. The data for each modality is sent automatically to a remote storage endpoint. With the help of one of the team members, it can then be retrieved, checked for validity, time aligned across modalities, as well as subjected to more modality-specific pre-processing. The compiled dataset is uploaded then to a remote storage endpoint that can be securely accessed by all team members for continued analysis. All machines with data access, especially for sensitive data such as raw video, are enclosed within a VPN that ensures all data is transferred securely and stored data is always encrypted. <a href="https://www.jove.com/files/ftp_upload/65305/65305fig01large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>

Author Spotlight: Automated Deep Brain Stimulation for Parkinson&#039;s Disease - Exploring the Possibilities and Challenges of Home Monitoring 

Bringing the Clinic Home: An At-Home Multi-Modal Data Collection Ecosystem to Support Adaptive Deep Brain Stimulation

My research supports automating adaptive deep brain stimulation or ADBS for Parkinson's disease in the comfort of someone's home. One question is whether this therapy can be monitored safely for a long period outside the clinic while ensuring patient privacy. Additionally, we're looking into the possibility of automatically adjusting ADBS parameters without the need for the patient to return to the clinic.ADBS research needs data collection platforms to accurately measure movement quality as patients go about their daily lives and to remotely deliver updates to therapy algorithms. This protocol collects multiple modalities as patients move freely about their homes, including video data to capture isolated kinematic like finger movements. Our results allow us to explore changes in Parkinson's disease over long periods of time, and they let us ask what measurements are necessary to analyze and treat the varied symptoms of Parkinson's disease outside clinical observation.

Watch this Scientific Journal Video about Prototype of the At-Home Multi-Modal Data Collection Platform for Adaptive Deep Brain Stimulation at JoVE.com

Prototype of the At-Home Multi-Modal Data Collection Platform for Adaptive Deep Brain Stimulation  

Begin by running the commands to install and configure an uncomplicated firewall in the PC terminal. For the server VPN installation, execute the installation of the open-source WireGuard VPN protocol on the computer. Navigate actively to the installation directory and run the unmask 007 command in the PC terminal to update the directory access rules appropriately.Then run the command to generate a public or private key pair for the VPN server in the PC terminal, which can be shared with any client PC that connects to the VPN. Next, run the commands to create a server configuration file and paste the server rules into this file. Enter the command to activate the VPN.Also execute the command to program the VPN protocol to launch each time the PC reboots automatically. Take the public key from the configuration file, generated during installation and paste it into the peer section of the server's configuration file. Set up a new client tunnel, copy the client public key and paste it into the server configuration file.Now copy the software link from GitHub and install the software on the computer to schedule and control video recordings. Choose a monitor that will show the video recording and process and allows users to terminate recordings seamlessly. Select USB-compatible webcams that offer a high resolution to accurately calculate poses within the designated space.Identify a space for webcam installation that offers minimal disruptions to the home environment. Then mount the webcams in this designated area, using the selected mounting hardware. After discussing a suitable recording schedule with the patient, set this schedule in the video-recording software.Confirm that the PC is equipped with the latest version of the chosen video-recording software, using the GitHub machine user account installed earlier. Next, log into the PC, using the installed remote desktop software and activate the video-recording software. Acquire a checkerboard pattern to support the 3D calibration of the pose-estimation software.Capture a video from each webcam, ensuring the checkerboard is angled appropriately within the frame for all cameras. To initiate data collection, request the patient to inspect the battery and power supply of the INS device to ensure it remains on for continuous stimulation. Request the patient to activate the tablet PC and verify that the CTM for the left and right INS devices are switched on and fully charged.Prior to any data collection, the patient has two INS devices implanted in both sides of their chest. Instruct the patient to position the CTMs on both sides of their chest. Upon the tablet's activation, request the patient to launch the Deep-Brain Stimulation or DBS application and select the connect option to initiate a Bluetooth connection with the CTMs and ultimately the INS devices.Ask the patient to turn on their smartwatches and smartphones by pressing the power button. Further, direct them to open the smartwatch application to initiate data recording and Parkinson's disease symptom tracking. To ensure the reliability of timestamp alignment and multi-device clock-based synchronization, instruct the patient to perform a specific gesture at the start of each new recording session.Switch the stimulation group to the patient's preferred clinically assigned team. Submit a symptom report on the patient-facing graphical user interface of the DBS application. Then close the DBS application to disconnect the clinical trial monitors and stop the INS streaming.In the manual time, align the graphical user interface and overlay data streams for visualization. Zoom in on the time axis and move the viewing window to the chest-tapping portion of the recording. Adjust the alignment for peak chest taps overlap between INS and smartwatch signals.Ensure the alignment consistency throughout the time series. Then hit the switch-aligning key and initiate alignments on any remaining data streams. In 1.5 years, 293 hours of INS data, 224 hours of smartwatch data and 2037 hours of video data across three webcams were recorded, which allows longitudinal changes in neural data to be observed.Kinematic trajectories of movement, including isolated finger movements that cannot be captured by a smartwatch can be obtained through pose estimates. These estimates can be analyzed together with other recorded modalities.

prototype-at-home-multi-modal-data-collection-platform-for-adaptive

Research

JoVE Journal

Neuroscience

97 Views.  University of Washington. Begin by running the commands to install and configure an uncomplicated firewall in the PC terminal. For the server VPN installation, execute the installation of the open-source WireGuard VPN protocol on the computer. Navigate actively to the installation directory and run the unmask 007 command in the PC terminal to update the directory access rules appropriately.Then run the command to generate a public or private key pair for the VPN server in the PC terminal, which can be shared wi...