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

NCT06359561 | Enrolling By Invitation

• 1 other identifier: 2023-2201 - Cervical lead
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 3months, 6 months, 12 months

Secondary Outcomes (8)

• Pain distribution using Patient Reported Dermatomal Coverage Map

  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

  baseline, 3months, 6 months, 12 months

• Pain-related medication intake.

  baseline, 3months, 6 months, 12 months

• Programming parameters.

  3months, 6 months, 12 months

• Programming parameters.

  3months, 6 months, 12 months

Study Arms (1)

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.

Device: cervical lead placement

Interventions

cervical lead placement DEVICE

implant of cervical lead neurostimulation, using saluda medical devices

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Saluda Medical Pty Ltd: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6815AD, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 16095934 BACKGROUND

• 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.

  PMID: 15029914 BACKGROUND

• 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.

  PMID: 25112889 BACKGROUND

• 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.

  PMID: 15109517 BACKGROUND

• 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.

  PMID: 34236671 BACKGROUND

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD dr.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 11, 2024
• Study Start: October 5, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)