Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy

Karel Hanssens1 site in 1 country12 target enrollmentAugust 2, 2023

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Karel Hanssens
Enrollment: 12
Locations: 1
Primary Endpoint: Number of participants with change in stimulation sensation
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2023

End Date

December 2029

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Karel Hanssens

Responsible Party

Sponsor Investigator

Principal Investigator

Karel Hanssens

AZ Delta

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of participants with change in stimulation sensation

Time Frame: 6-months

Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.

Secondary Outcomes

NRS(Baseline, 3-months, 6-months, 12-months post-implant)
Number of participants with reduced pain distribution(Baseline, 3-months, 6-months and 12-months post-implant)
Paraesthesia mapping(3-months, 6-months and 12-months post-implant)