Differential Target Multiplexed Spinal Cord Stimulation (DETECT)

Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study

Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.

Study Overview

• Status: Recruiting
• Conditions: Failed Back Surgery Syndrome; Persistent Spinal Pain Syndrome Type 2
• Intervention / Treatment: Device: Spinal Cord Stimulation

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Maarten Moens, prof.dr.; Phone Number: +3224775514; Email: maarten.moens@uzbrussel.be
• Study Contact Backup: Name: Lisa Goudman, PhD; Phone Number: +3224775514; Email: lisa.goudman@gmail.com

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Recruiting
    • ZNA
    • Contact: Michel Turlot, MD
  • Brugge, Belgium
    • Recruiting
    • AZ Sint-Jan Brugge-Oostende
    • Contact: Mayken Gorissen, MD
  • Brugge, Belgium
    • Recruiting
    • AZ Sint-Lucas Brugge
    • Contact: Mayken Gorissen, MD
  • Hasselt, Belgium
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Mark Plazier, MD, PhD
  • Kortrijk, Belgium
    • Recruiting
    • AZ Groeninge
    • Contact: Pieter-Jan Germonpre, MD
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Tom Theys, MD, PhD
  • Lier, Belgium
    • Recruiting
    • Heilig Hart Ziekenhuis Lier
    • Contact: Sofie Denkens, MD
  • Liège, Belgium
    • Recruiting
    • Centre Hospitalier Regional (CHR) de la Citadelle
    • Contact: Thibault Remacle, MD, PhD
  • Mechelen, Belgium
    • Recruiting
    • Az Sint-Maarten
    • Contact: Johan Vangeneugden, MD
  • Roeselare, Belgium
    • Recruiting
    • AZ Delta
    • Contact: Bart Billet, MD
  • Sint-Niklaas, Belgium
    • Recruiting
    • VITAZ
    • Contact: Jean-Pierre Van Buyten, MD, PhD
  • Turnhout, Belgium
    • Recruiting
    • Az Turnhout
    • Contact: Bart Bryon, MD
  • Wilrijk, Belgium
    • Recruiting
    • GZA
    • Contact: Raf Van Paesschen, MD
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Maarten Moens, prof. dr.; Phone Number: +3224775514; Email: maarten.moens@uzbrussel.be
      • Contact: Lisa Goudman, PhD; Phone Number: +3224775514; Email: lisa.goudman@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic back and leg pain due to Failed Back Surgery Syndrome (FBSS)/Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.

Description

Inclusion Criteria:

• Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
• Age > 18 years
• Patient has been informed of the study procedures and has given written informed consent
• Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

• Expected inability of the patient to receive or properly operate the spinal cord stimulation system
• History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
• Active malignancy
• Addiction to drugs, alcohol (>5 units per day) and/or medication
• Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator
• Immune deficiency (e.g. HIV positive, immunosuppressive treatment)
• Life expectancy < 1 year
• Local infection or any other skin disorder at site of incision
• Pregnancy
• Other implanted active medical device

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal cord stimulation; Patients will receive differential target multiplexed spinal cord stimulation	Device: Spinal Cord Stimulation; differential target multiplexed stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall pain intensity with Visual Analogue Scale (VAS)	Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain intensity with Visual Analogue Scale (VAS)		The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Leg pain intensity with Visual Analogue Scale (VAS)		The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain medication use	Open question regarding the dosage, frequency and type of pain medication	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Functional disability	The functional disabilities will be assessed with the Oswestry Disability Index (ODI)	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Health related quality of life	Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patient global impression of change	Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC).	Evaluated at 1 month, 6 months and 12 months of DTM SCS.
Clinical holistic responder status		The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patients' individual competencies for self-management	Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health.	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Work status	Work status is evaluated with a self-designed questionnaire	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain catastrophizing	The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Symptoms of central sensitisation.	The Central Sensitization Inventory is used to measure symptoms of central sensitisation	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Anxiety and Depression.	The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Healthcare utilisation.	Postoperative healthcare expenditure will be investigated by self-reporting methods.	The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS
Time spent in body postures	Based on the AdaptiveStim technology, the time spent in body postures can be recorded.	The data will be extracted from SCS implantation up to 1 month of SCS, from 1 month of SCS up to 6 months and from 6 months up to 12 months
(Serious) adverse events	Systematically recording all adverse events	Throughout study period
Proportion of successful DTM trials.		Evaluated after final SCS implantation
Battery consumption		Registration at 1 month, 6 months and 12 months of DTM SCS
Prevalence of technical issues with regard to DTM SCS programming		Throughout study period
DTM SCS stimulation parameters		Registration at 1 month, 6 months and 12 months of DTM SCS
Patient expectations concerning SCS	Self-constructed open question to evaluate patient expectations about SCS	Evaluated at baseline visit

Collaborators and Investigators

• Sponsor: Moens Maarten

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: differential target multiplexed spinal cord stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: DETECT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No