Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Recruiting

• Conditions: Chronic Pain; Neuropathic Pain; Persistent Spinal Pain Syndrome Type 2

• Registration Number: NCT06775535
• Lead Sponsor: Karel Hanssens

Brief Summary

Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.

Detailed Description

The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\' sensation.

Study Timeline

• Study Start: 2023-08-02
• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2028-08
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
• Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
• Subject is ≥ 18 years old.
• Subject is not pregnant or nursing.
• Subject is willing and capable of giving informed consent.

Exclusion Criteria

• Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
• Subject is incapable of understanding or responding to the study questionnaires.
• Subject is incapable of understanding or operating the patient programmer handset.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with change in stimulation sensation	6-months	Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.

Secondary Outcome Measures

Name	Time	Method
NRS	Baseline, 3-months, 6-months, 12-months post-implant	The numeric rating scale (NRS) is a pain screening tool. It is used to assess pain severity at that moment in time using a 0-10 scale. Zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Number of participants with reduced pain distribution	Baseline, 3-months, 6-months and 12-months post-implant	Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain.
Paraesthesia mapping	3-months, 6-months and 12-months post-implant	Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia.

Trial Locations

Locations (1)

AZ Delta; 🇧🇪 Roeselare, Belgium