Chronic Pain SyndromeNCT06359561

Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients with Cervical Lead Placement

An observational study of Chronic Pain Syndrome and Multi Focal Pain, run by Rijnstate Hospital at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain Syndrome, Multi Focal Pain, Failed Neck Surgery Syndrome
What is being tested?: cervical lead placement
Type of treatment: Medical device
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: 5 Oct 2023to 31 Dec 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Rijnstate Hospital
Arnhem, Gelderland, 6815AD

Other trials in Netherlands

About this study

Official title: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord

Read the 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.

Conditions: Chronic Pain Syndrome, Multi Focal Pain, Failed Neck Surgery Syndrome, Polyneuropathies
Being tested: cervical lead placement
Keywords: Spinal cord stimulation, Cervical lead placement, Closed loop stimulation, Multi focal pain
Medical subject headings: Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cervical lead placementDevice
implant of cervical lead neurostimulation, using saluda medical devices

Study groups in NCT06359561
Study group	Role	What they receive
single arm		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. Receives: Device: cervical lead placement

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline, 3months, 6 months, 12 months

Secondary outcomes (8)

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."
Measured: 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).
Measured: baseline, 3months, 6 months, 12 months
Pain-related medication intake.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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."
Measured: 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.
Measured: 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202331 Dec 2025

First posted11 Apr 2024
Study start5 Oct 2023
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06359561
Sponsor's protocol ID: 2023-2201 - Cervical lead
Status last verified: Apr 2024
First submitted: 27 Feb 2024
Last updated: 15 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
PubMed 16095934
Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254.
PubMed 15029914
Deer TR, Mekhail N, Provenzano D, Pope J, Krames E, Leong M, Levy RM, Abejon D, Buchser E, Burton A, Buvanendran A, Candido K, Caraway D, Cousins M, DeJongste M, Diwan S, Eldabe S, Gatzinsky K, Foreman RD, Hayek S, Kim P, Kinfe T, Kloth D, Kumar K, Rizvi S, Lad SP, Liem L, Linderoth B, Mackey S, McDowell G, McRoberts P, Poree L, Prager J, Raso L, Rauck R, Russo M, Simpson B, Slavin K, Staats P, Stanton-Hicks M, Verrills P, Wellington J, Williams K, North R; Neuromodulation Appropriateness Consensus Committee. The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014 Aug;17(6):515-50; discussion 550. doi: 10.1111/ner.12208.
PubMed 25112889
Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain. 2004 Mar;108(1-2):137-47. doi: 10.1016/j.pain.2003.12.016.
PubMed 15109517
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.
PubMed 34236671

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord
ClinicalTrials.gov ID: NCT06359561
Acronym / sponsor ID: 2023-2201 - Cervical lead
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
Study type: Observational
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Rijnstate HospitalUniversity, hospital or other
Collaborators: Saluda Medical Pty Ltd
Study start: 5 Oct 2023 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 11 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
single arm	–	Device: cervical lead placementUp 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cervical lead placementimplant of cervical lead neurostimulation, using saluda medical devices	Device	single arm

Primary outcome

Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS)
Time frame: baseline, 3months, 6 months, 12 months
NRS scoring: 0 no pain, 10 worst imaginable pain

8 secondary outcomes

Pain distribution using Patient Reported Dermatomal Coverage Map
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
Time frame: baseline, 3months, 6 months, 12 months
Pain-related medication intake.
Time frame: baseline, 3months, 6 months, 12 months
Programming parameters.
Time frame: 3months, 6 months, 12 months
Programming parameters.
Time frame: 3months, 6 months, 12 months
Evaluate stimulation sensation (awareness and quality)
Time frame: 3months, 6 months, 12 months
Evaluate stimulation coverage in pain region(s)
Time frame: 3months, 6 months, 12 months
Posture Change Measurements
Time frame: 6 months, 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Background: PubMed 16095934Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
Background: PubMed 15029914Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254.
Background: PubMed 25112889Deer TR, Mekhail N, Provenzano D, Pope J, Krames E, Leong M, Levy RM, Abejon D, Buchser E, Burton A, Buvanendran A, Candido K, Caraway D, Cousins M, DeJongste M, Diwan S, Eldabe S, Gatzinsky K, Foreman RD, Hayek S, Kim P, Kinfe T, Kloth D, Kumar K, Rizvi S, Lad SP, Liem L, Linderoth B, Mackey S, McDowell G, McRoberts P, Poree L, Prager J, Raso L, Rauck R, Russo M, Simpson B, Slavin K, Staats P, Stanton-Hicks M, Verrills P, Wellington J, Williams K, North R; Neuromodulation Appropriateness Consensus Committee. The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014 Aug;17(6):515-50; discussion 550. doi: 10.1111/ner.12208.
Background: PubMed 15109517Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain. 2004 Mar;108(1-2):137-47. doi: 10.1016/j.pain.2003.12.016.
Background: PubMed 34236671Surges 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.
Individual participant dataSharing planned: No

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Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain Syndrome and Multi Focal Pain, run by Rijnstate Hospital at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS) (time frame: baseline, 3months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06359561, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.