Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT06853795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Validation Study of an E-health Tool for Patient Selection for SCS
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
European E-health Tool for the Appropriate (pre)selection for Spinal Cord Stimulation in Patients with Chronic Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn more about the selection of patients with chronic pain for spinal cord stimulation. The main question it aims to answer is to assess the predictive value of an e-health tool for patient outcomes.
Participants will be treated as normal and will be asked to complete patient questionnaires to evaluate their pain relief after receiving spinal cord stimulation. The e-health tool will not be used during the conduct of the study, as patient outcomes will only at the end of the study be compared with the recommendations made by the e-health tool.
Participants will be treated as normal and will be asked to complete patient questionnaires to evaluate their pain relief after receiving spinal cord stimulation. The e-health tool will not be used during the conduct of the study, as patient outcomes will only at the end of the study be compared with the recommendations made by the e-health tool.
Detailed Description:
This is a multicentre study within Europe, prospectively collecting data from patients with a positive decision on SCS, receiving either a direct implant or an SCS screening trial. Data will be collected by implant centres who have not previously used the e-health tool for SCS patient selection (i.e. tool-naïve). Furthermore, participating centres should declare neither to use the tool during the conduct of study nor on patients included in the study population. In addition, participating implant centres should have previous experience in conducting prospective clinical trials.
Baseline data should be collected at the moment of the final decision on SCS (i.e., after multidisciplinary team consultation if applicable) using an online data capture program:
* General baseline data
* e-Health tool variables
* Centre decision on SCS (direct implant or trial)
Only for patients receiving SCS (direct implant or positive trial), follow-up data at 6 and 12 months will be collected.
Afterwards, the prospectively collected data will be applied to the e-health tool and its recommendations compared with the centre decisions, trial results and patient outcomes.
Baseline data should be collected at the moment of the final decision on SCS (i.e., after multidisciplinary team consultation if applicable) using an online data capture program:
* General baseline data
* e-Health tool variables
* Centre decision on SCS (direct implant or trial)
Only for patients receiving SCS (direct implant or positive trial), follow-up data at 6 and 12 months will be collected.
Afterwards, the prospectively collected data will be applied to the e-health tool and its recommendations compared with the centre decisions, trial results and patient outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: