An observational study in Chronic Pain Syndrome, Multi Focal Pain and Failed Neck Surgery Syndrome, sponsored by Rijnstate Hospital. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Rijnstate Hospital · Observational
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.
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
Inclusion criteria
Burden and Risk
133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 53 observational studies indexed under Polyneuropathies.
Browse Polyneuropathies studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: cervical lead placement
implant of cervical lead neurostimulation, using saluda medical devices
Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS)
NRS scoring: 0 no pain, 10 worst imaginable pain
Time frame: baseline, 3months, 6 months, 12 months
Pain distribution using Patient Reported Dermatomal Coverage Map
Subjects will be asked to map and track pain distribution (extent and location) by shading in the areas where they typically experience pain on a body map drawing. "Shade in the areas where you typically experience "study pain" on the pain map below. If the pain goes from front to back, then shade in those areas on each side of the picture."
Time frame: baseline, 3months, 6 months, 12 months
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
The PROMIS 29+2 Profile v2.1 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. The first seven domains are assessed with 4 questions each. High scores represent more of the domain being measured. Thus, on symptom-oriented (negatively worded) domains of PROMIS 29+2 Profile v2.1 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function-oriented (positively worded) domains (physical functioning and social role) higher scores represent better functioning. Pain Intensity is measured with a single 11-point numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain).
Time frame: baseline, 3months, 6 months, 12 months
Pain-related medication intake.
Time frame: baseline, 3months, 6 months, 12 months
Programming parameters.
Program parameters (e.g., leads programmed: configuration ) will be collected. This data is automatically recorded on the SCS-device.
Time frame: 3months, 6 months, 12 months
Programming parameters.
Program parameters (e.g., pulsed width recorded in unit: micro seconds) will be collected. This data is automatically recorded on the SCS-device.
Time frame: 3months, 6 months, 12 months
Evaluate stimulation sensation (awareness and quality)
Subject will be asked how aware he/she is of the stimulation sensation and is presented with a 5-point rating scale containing the options "Always aware of stimulation sensation", "Usually aware of stimulation sensation", "Sometimes aware of stimulation sensation", "Rarely aware of stimulation sensation", and "Never aware of stimulation sensation". Subjects will be asked a question about stimulation sensation quality and can rate from "Unpleasant", "Neither pleasant nor unpleasant", "Pleasant" to "No sensation".
Time frame: 3months, 6 months, 12 months
Evaluate stimulation coverage in pain region(s)
Subjects will be asked to map and track stimulation distribution (extent and location) by shading in the areas where they typically experience stimulation sensation on a body map drawing. "Shade in the areas where you typically experience stimulation on the body map below. If the stimulation goes from front to back, then shade in those areas on each side of the picture."
Time frame: 3months, 6 months, 12 months
Posture Change Measurements
Data on stimulation intensity and ECAP amplitude at various stimulation levels (i.e., activation plot) and in different postures will be collected in both stimulation modes. Subjects will rate the stimulation intensity on an 11-point numeric rating scale (0 equals "no feeling" and 10 equals "very intense"). All these measurements are automatically recorded on the device except subject ratings, which will be recorded on the CRF.
Time frame: 6 months, 12 months
Plan to share: No
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