Differential Target Multiplexed Spinal Cord Stimulation
DETECT
1 other identifier
observational
250
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
October 5, 2021
CompletedStudy Start
First participant enrolled
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
August 16, 2024
August 1, 2024
4.8 years
September 9, 2021
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (20)
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
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Functional disability
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Health related quality of life
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
- +15 more secondary outcomes
Study Arms (1)
Spinal cord stimulation
Patients will receive differential target multiplexed spinal cord stimulation
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
Study Sites (14)
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090, Belgium
ZNA
Antwerp, Belgium
AZ Sint-Jan Brugge-Oostende
Bruges, Belgium
AZ Sint-Lucas Brugge
Bruges, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
Heilig Hart Ziekenhuis Lier
Lier, Belgium
Centre Hospitalier Régional (CHR) de la Citadelle
Liège, Belgium
AZ Sint-Maarten
Mechelen, Belgium
AZ Delta
Roeselare, Belgium
Vitaz
Sint-Niklaas, Belgium
AZ Turnhout
Turnhout, Belgium
GZA
Wilrijk, Belgium
Related Publications (1)
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.
PMID: 39521475DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 9, 2021
First Posted
October 5, 2021
Study Start
October 6, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 16, 2024
Record last verified: 2024-08