Clinical trial NCT06359561: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients with Cervical Lead Placement
Official title: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Pain Syndrome
Multi Focal Pain
Failed Neck Surgery Syndrome
Polyneuropathies
Keywords: Spinal cord stimulation
Cervical lead placement
Closed loop stimulation
Multi focal pain
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Saluda Medical Pty Ltd
First posted: 2024-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects eligible for SCS trial and permanent implant will be recruited to participate in the study. Subjects will read and sign an informed consent prior to study participation. Subjects meeting all the inclusion and none of the exclusion criteria and receiving a permanent implant with cervical lead placement will be considered enrolled. Up to 40 subjects receiving a permanent implant will be enrolled.

Brief summary: This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement.

Detailed description: Title Assessment of effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement.

Device used in the study The Saluda Medical EvokeTM Closed-Loop Spinal Cord Stimulator (CL-SCS) System (Evoke System). The CE marked Evoke System will be used within its licensed use and manuals. The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode.

Indication for use The Evoke SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs and will be used within its licensed indication during this study.

Rational This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement.

Study design An observational, prospective, multi-center, single-arm study. Study population Up to 40 subjects eligible for SCS trial and permanent implant with a minimum of pain intensity of 5/10 on NRS at baseline will be enrolled.

Objectives

* Evaluate stimulation coverage in pain area and other parts of the body, sensation (awareness and quality) and pain relief using a 0-10 numeric rating score (NRS) in patient implanted with one or two leads at cervical level receiving closed-loop spinal cord stimulator (CL-SCS) therapy.
* Assessment of holistic outcomes: measure quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire.
* Evaluate medication intake, patient satisfaction and patient global impression of change (PGIC).
* Assessment of device data and programming parameters.
* Neurophysiological measurements: neuronal activation, conduction velocity and posture change assessment.

Inclusion criteria

* Subject is deemed a suitable candidate for SCS trail and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
* 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.

Burden and Risk

* There will be no additional burden associated with participation in the study. The data will be collected during the standard of care visits. Data collection required by the study protocol will add no additional time to standard clinical appointments, as the data will be downloaded from the clinical interface or entered directly into the database.
* The benefits of this study could enable improved treatment of chronic trunk and/or limb pain with the closed loop system and cervical lead placement.

Eligibility criteria: Inclusion Criteria:

* Subject is deemed a suitable candidate for SCS trail and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
* 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.

Primary outcomes:
measure: Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS)
timeFrame: baseline, 3months, 6 months, 12 months
Secondary outcomes:
measure: Pain distribution using Patient Reported Dermatomal Coverage Map
timeFrame: baseline, 3months, 6 months, 12 months
measure: Assessment of holistic outcomes: quality of life in seven domains (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire
timeFrame: baseline, 3months, 6 months, 12 months
measure: Pain-related medication intake.
timeFrame: baseline, 3months, 6 months, 12 months
measure: Programming parameters.
timeFrame: 3months, 6 months, 12 months
measure: Programming parameters.
timeFrame: 3months, 6 months, 12 months
measure: Evaluate stimulation sensation (awareness and quality)
timeFrame: 3months, 6 months, 12 months
measure: Evaluate stimulation coverage in pain region(s)
timeFrame: 3months, 6 months, 12 months
measure: Posture Change Measurements
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
References:
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citation: Surges G, Paulus J, Blass T, Mendryscha K, Bettag M, Rotte A. Efficacy and Safety of 10 kHz Spinal Cord Stimulation Using Cervical and Thoracic Leads: A Single-Center Retrospective Experience. Pain Ther. 2021 Dec;10(2):1255-1268. doi: 10.1007/s40122-021-00287-4. Epub 2021 Jul 8.