This study explores the use of an implantable neurostimulator (INS) in patients diagnosed with depression. The INS records brain activity through electrocorticography to detect abnormal patterns associated with depressive symptoms.
Begin with a patient diagnosed with depression, implanted with an implantable neurostimulator or INS.
The INS uses cortical and depth electrodes to record brain activity through electrocorticography, detecting abnormal patterns linked to depression.
Connect a telemetry wand to the programmer and position it over the INS for wireless communication.
Log into the patient’s data-management system.
Adjust the electrocorticography recording settings.
Swipe a magnet over the INS to trigger the first recording.
The patient then completes a symptom survey, documenting his emotional state.
Once the survey is complete, swipe the magnet again to trigger a second recording, capturing
brain activity changes during symptom reporting.
Place the wand over the INS to transfer data from both recordings to the system.
Doctors analyze the recordings and symptom reports to identify a personalized biomarker—a unique brain activity pattern linked to symptom severity.
The INS delivers closed-loop neurostimulation only when this biomarker is detected.
To begin, ensure the patient has fully recovered from surgery following the implantation of the device with cortical in-depth leads. Connect the telemetry wand to the programmer and instruct the patient to hold it over the implantable neurostimulator to attach it to a tethering hat. Using the programmer, log on to the patient data management system.
Navigate to the correct patient, select programming, and then choose the change ECoG capture option. Proceed the set the capture window to a maximum of 240 seconds for the four configured channels, using the dropdown selection. Using the dropdown selections, set the reserved space for magnet reservations to 2 and the value to 0 for any other trigger types. Select the review and program button to synchronize the newly programmed settings with the patient's implantable neurostimulator. Verify any changes in the table and select the Confirm programming button.
To prepare for the patient's symptom report survey, use a web-based survey tool such as REDCap, including sliders for VAS-D, VAS-A, VAS-E, and selection responses for each question of the HAMD-6. Ensure to log the time of survey start and completion. Provide the patient with the unique URL generated by REDCap for assessing the symptom surveys through either email or text message.
Instruct the patient to set up the equipment, including the remote monitor and wand, magnet and device, for completing the survey. Turn on the remote monitor and using the wand, interrogate the device. Then download the electrocorticography recordings since the last interrogation to the remote monitor.
Swipe the magnet over the implantable neurostimulator to trigger a magnet recording. Start a timer and use the previously generated unique REDCap URL to complete the symptom survey. After four minutes have elapsed or the patient completes the survey, whichever is longer, the patient will swipe the magnet over the implantable neurostimulator again to trigger another recording.
After at least 80 seconds, use the wand to interrogate the device again and transfer the data from the two magnet swipes to the remote monitor. At least once a day, connect the remote monitor to the internet using Ethernet and select Transfer Data and synchronize on the remote monitor to send the collected data to the cloud.
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