Persistent Pain SyndromeNCT07865806
Understanding Spinal Cord Stimulation in Daily Life: Data Collection Via Smartwatch, Patient Questionnaires, and Stimulation Settings
An observational study of Persistent Pain Syndrome, run by Julia Mahler.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Pain Syndrome
- What is being tested?
- Wearable-Based Continuous Physiological Monitoring with Implantable Pulse Generator (IPG) Data Correlation
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing evaluation for spinal cord stimulation (SCS) trial implantation for chronic back and/or leg pain following prior spinal surgery, who subsequently proceed to definitive implantable pulse generator (IPG) implantation after a successful trial stimulation, are eligible for inclusion. Patients are recruited from the outpatient neurosurgical clinic setting prior to their planned SCS trial. Only patients who go on to receive a permanent IPG implant are included in the final analysis cohort; those with a negative trial stimulation who do not proceed to permanent implantation are not included.
Who may be able to join
- Adults aged 18 years or older
- Symptoms consistent with PSPS types 1 and 2
- Evaluation of a first-time SCS trial implantation
- Ownership of a smartphone or access to an internet-enabled device compatible with the study platform and and wearable and he ability to use the study platform
- Willingness to consistently wear a wearable device throughout the entire study period
- Written informed consent
- Sufficient German language skills for written patient education and valid PROM assessment
- For patients > 65 years of age, MoCA score >25
Who cannot join
- Mild or severe cognitive (MoCA score <25) or psychiatric disorders with significant impairment of study compliance (e.g. bipolar or schizoaffective disorders, severe depression)
- Concomitant neurological or orthopedic conditions that significantly limit mobility or gait (e.g., spastic paresis, gait ataxia, Parkinson's disease, severe coxarthrosis, history of amputation)
- Previous SCS (test) implantation
- Cardiovascular diseases that impair interpretation of heart rate or HRV (e.g., atrial fibrillation, pacemaker dependency)
- Skin conditions or allergies that make it impossible to wear a wearable device continuously
- Language or communication barriers
- Concurrent participation in interventional studies that alter stimulation settings or pain management in a protocol-controlled manner
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation of Wearable-Based Physiological Parameters, Patient-Reported Outcomes, and Stimulation Settings in Patients With Spinal Cord Stimulation
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.
- Conditions
- Persistent Pain Syndrome
- Being tested
- Wearable-Based Continuous Physiological Monitoring with Implantable Pulse Generator (IPG) Data Correlation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable-Based Continuous Physiological Monitoring with Implantable Pulse Generator (IPG) Data CorrelationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| SCS Implant Cohort | Not described Receives: Device: Wearable-Based Continuous Physiological Monitoring with Implantable Pulse Generator (IPG) Data Correlation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient from a linear mixed model quantifying the association between daily step count (wrist-worn wearable) and the Oswestry Disability Index adjusted for IPG stimulation settings and measurement time point
Measured: 2 weeks preoperative and 2 and 6 weeks, 3, 6, and 12 months postoperative
Correlation coefficient from a linear mixed model quantifying the association between heart rate (wrist-worn wearable) and the Oswestry Disability Index, adjusted for IPG stimulation settings and measurement time point
Measured: 2 weeks preoperative and 2 and 6 weeks, 3, 6, and 12 months postoperative
Correlation coefficient from a linear mixed model quantifying the association between heart rate variability and the Oswestry Disability Index, adjusted for IPG stimulation settings and measurement time poi
Measured: 2 weeks preoperative and 2 and 6 weeks, 3, 6, and 12 months postoperative
Mean daily step count recorded via wrist-worn wearable device over consecutive two-week measurement windows, adjusted for IPG stimulation settings, modeled using a linear mixed model.
Measured: 2 weeks preoperative to 12 months postoperative, assessed in biweekly measurement windows
Mean resting heart rate recorded via wrist-worn wearable device over consecutive two-week measurement windows, adjusted for IPG stimulation settings, modeled using a linear mixed model
Measured: 2 weeks preoperative to 12 months postoperative, assessed in biweekly measurement windows
Mean heart rate variability recorded via wrist-worn wearable device over consecutive two-week measurement windows, adjusted for IPG stimulation settings, modeled using a linear mixed model.
Measured: 2 weeks preoperative to 12 months postoperative, assessed in biweekly measurement windows
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Persistent Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julia Mahler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Mahler, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865806
- Sponsor's protocol ID
- KSSG-NCH-SCS-2026
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Do TT, Smet I, Jerjir A, Vandamme K, Devos M, Van Buyten JP. Real-World Analysis: Long-Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome. Pain Pract. 2021 Feb;21(2):215-225. doi: 10.1111/papr.12952. Epub 2020 Oct 21.
PubMed 32964562Goudman L, Brouns R, Linderoth B, Moens M. Effects of Spinal Cord Stimulation on Heart Rate Variability in Patients With Failed Back Surgery Syndrome: Comparison Between a 2-lead ECG and a Wearable Device. Neuromodulation. 2021 Apr;24(3):512-519. doi: 10.1111/ner.13091. Epub 2019 Dec 25.
PubMed 31876094Venkatraman V, Bharmi R, Coletti F, Gellad ZF, Lempel N, Amit R, Blank N, Brown J, Kumar C, Fishman M, Vallejo R, Datta D, Reeve BB, Chakravarthy K, Sharan AD, Lad SP. Real World Characterization of Chronic Pain, Success Rates and Implant Rates: Evidence from a Digital Health Platform of Patients Undergoing Spinal Cord Stimulation Evaluations. J Pain. 2023 Dec;24(12):2228-2239. doi: 10.1016/j.jpain.2023.07.008. Epub 2023 Aug 2.
PubMed 37541604Deer TR, Esposito MF, Cornidez EG, Okaro U, Fahey ME, Chapman KB. Teleprogramming Service Provides Safe and Remote Stimulation Options for Patients with DRG-S and SCS Implants. J Pain Res. 2021 Oct 14;14:3259-3265. doi: 10.2147/JPR.S332966. eCollection 2021.
PubMed 34703301Bernaerts L, Roelant E, Lecomte F, Moens M, Van Buyten JP, Billet B, Bryon B, Puylaert M, Turgay T, Malone M, Theys T, Van Zundert J, Berquin A, Crombez E, De Coster O, Vangeneugden J, Ly HG, Louagie M, Hans GH. Large-scale real-world data on a multidisciplinary approach to spinal cord stimulation for persistent spinal pain syndromes: first evaluation of the Neuro-Pain(R) nationwide screening and follow-up interactive register. Front Neurosci. 2024 Mar 22;18:1322105. doi: 10.3389/fnins.2024.1322105. eCollection 2024.
PubMed 38586192Deer TR, Grider JS, Lamer TJ, Pope JE, Falowski S, Hunter CW, Provenzano DA, Slavin KV, Russo M, Carayannopoulos A, Shah JM, Harned ME, Hagedorn JM, Bolash RB, Arle JE, Kapural L, Amirdelfan K, Jain S, Liem L, Carlson JD, Malinowski MN, Bendel M, Yang A, Aiyer R, Valimahomed A, Antony A, Craig J, Fishman MA, Al-Kaisy AA, Christelis N, Rosenquist RW, Levy RM, Mekhail N. A Systematic Literature Review of Spine Neurostimulation Therapies for the Treatment of Pain. Pain Med. 2020 Nov 7;21(7):1421-1432. doi: 10.1093/pm/pnz353.
PubMed 32034422Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007 Nov;132(1-2):179-88. doi: 10.1016/j.pain.2007.07.028. Epub 2007 Sep 12.
PubMed 17845835