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Objective Data on Daily Activity in Patients Treated with SCS: the Intellis Study

NCT04710355 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-01-16

No results posted yet for this study

Summary

In spinal cord stimulation (SCS), most outcome data are based on patient questionnaires. The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy. Currently, however, SCS-devices with an accelerator included are available on the market. The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life.

Conditions

  • Failed Back Surgery Syndrome

Interventions

DEVICE

Spinal cord stimulation

Adhesion of Intellis spinal cord stimulator to the skin of the abdomen for 4 weeks for baseline recording of activity level prior to trial with spinal cord stimulation.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Kliment Gatzinsky, MD, PhD · Sahlgrenska University Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Belgium
  • Denmark
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710355 on ClinicalTrials.gov