Differential Target Multiplexed Spinal Cord Stimulation

NCT ID: NCT05068011

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-06

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Failed Back Surgery Syndrome Persistent Spinal Pain Syndrome Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal cord stimulation

Patients will receive differential target multiplexed spinal cord stimulation

Spinal Cord Stimulation

Intervention Type DEVICE

differential target multiplexed stimulation

Interventions

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Spinal Cord Stimulation

differential target multiplexed stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moens Maarten

OTHER

Sponsor Role lead

Responsible Party

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Moens Maarten

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

ZNA

Antwerp, , Belgium

Site Status RECRUITING

AZ Sint-Jan Brugge-Oostende

Bruges, , Belgium

Site Status RECRUITING

AZ Sint-Lucas Brugge

Bruges, , Belgium

Site Status RECRUITING

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Heilig Hart Ziekenhuis Lier

Lier, , Belgium

Site Status RECRUITING

Centre Hospitalier Régional (CHR) de la Citadelle

Liège, , Belgium

Site Status RECRUITING

AZ Sint-Maarten

Mechelen, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Vitaz

Sint-Niklaas, , Belgium

Site Status RECRUITING

AZ Turnhout

Turnhout, , Belgium

Site Status RECRUITING

GZA

Wilrijk, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Maarten Moens, prof.dr.

Role: CONTACT

+3224775514

Lisa Goudman, PhD

Role: CONTACT

+3224775514

Facility Contacts

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Maarten Moens, prof. dr.

Role: primary

+3224775514

Lisa Goudman, PhD

Role: backup

+3224775514

Michel Turlot, MD

Role: primary

Mayken Gorissen, MD

Role: primary

Mayken Gorissen, MD

Role: primary

Mark Plazier, MD, PhD

Role: primary

Pieter-Jan Germonpre, MD

Role: primary

Tom Theys, MD, PhD

Role: primary

Sofie Denkens, MD

Role: primary

Thibault Remacle, MD, PhD

Role: primary

Johan Vangeneugden, MD

Role: primary

Bart Billet, MD

Role: primary

Jean-Pierre Van Buyten, MD, PhD

Role: primary

Bart Bryon, MD

Role: primary

Raf Van Paesschen, MD

Role: primary

References

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Goudman L, De Smedt A, Eldabe S, Rigoard P, Billot M, Roulaud M; DETECT consortium; Moens M. Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT). BMJ Open. 2024 Nov 9;14(11):e083610. doi: 10.1136/bmjopen-2023-083610.

Reference Type DERIVED
PMID: 39521475 (View on PubMed)

Other Identifiers

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DETECT

Identifier Type: -

Identifier Source: org_study_id

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