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Understanding Spinal Cord Stimulation in Daily Life: Data Collection Via Smartwatch, Patient Questionnaires, and Stimulation Settings
Sponsor: Julia Mahler
Summary
This study investigates how people do in everyday life after they receive spinal cord stimulation (SCS), a treatment used for long-term back and leg pain that has not improved with other treatments. Participants will already be scheduled to have this treatment as part of their normal medical care, whether or not they take part in the study. People who join the study will wear a smartwatch that records parameters like step count, heart rate, sleep quality, and activity level, starting about 2 to 4 weeks before their surgery and continuing for 12 months afterward. They will also answer short questionnaires about their pain, mood, and quality of life through a study app/website, and will receive educational information about their condition and their stimulation device. In addition, the settings of the implanted stimulation device will be recorded at the same time points. The goal is to see whether the information collected from the smartwatch and the questionnaires is related to the settings of the stimulation device and to how well people are doing over time. This may help doctors better understand how SCS affects daily life, and could help improve how patients are followed up and selected for this treatment in the future.
Official title: Prospective Evaluation of Wearable-Based Physiological Parameters, Patient-Reported Outcomes, and Stimulation Settings in Patients With Spinal Cord Stimulation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
35
Start Date
2027-01-01
Completion Date
2030-07-30
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Wearable-Based Continuous Physiological Monitoring with Implantable Pulse Generator (IPG) Data Correlation
Participants scheduled for spinal cord stimulation (SCS) as part of routine clinical care wear a commercially available wristband-type wearable device (e.g., smartwatch) continuously from approximately 4 weeks before the SCS trial through 12 months after definitive implantation of the pulse generator (IPG). The wearable passively records physiological and activity parameters (step count, heart rate, heart rate variability, sleep quality, stress level, activity level) via the study platform, which are synchronized every two weeks. At six defined study time points (2 weeks preoperative, 2 and 6 weeks, and 3, 6, and 12 months postoperative), these wearable-derived parameters are analyzed together with PROMS and IPG stimulation settings obtained through the patient's implanted device. The SCS therapy itself, including implantation and stimulation programming, is administered entirely according to standard clinical practice and is not altered or dict