Actively Recruiting

Age: 18Years +
All Genders
ID05068011

Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study for Chronic Back and Leg Pain

Led by Moens Maarten · Updated on 2024-08-16

250

Participants Needed

14

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how well differential target multiplexed (DTM) spinal cord stimulation works to treat chronic back and leg pain in patients with conditions like Failed Back Surgery Syndrome and Persistent Spinal Pain Syndrome Type 2. The study will also compare outcomes between patients using paddle or surgical leads and those using percutaneous leads to see if there are differences in effectiveness. Participants will receive spinal cord stimulation using the DTM approach as the main treatment. This device-based therapy will be monitored over time, with evaluations conducted at 1 month, 6 months, and 12 months after implantation. The study will collect detailed information on pain intensity, medication use, functional ability, quality of life, and other factors related to pain and daily living. During the study, participants will undergo assessments including pain ratings using the Visual Analogue Scale, measures of disability, psychological factors, and healthcare use. Data on device parameters, battery consumption, and any technical issues will also be tracked. Safety will be monitored by recording any adverse events throughout the study period. Overall, the study involves regular follow-up visits and evaluations over a year to understand the impact of DTM spinal cord stimulation on chronic pain.

CONDITIONS

Brief Title

Differential Target Multiplexed Spinal Cord Stimulation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe chronic pain (> 5 on numeric rating scale) for at least 6 months due to Failed Back Surgery Syndrome or Persistent Spinal Pain Syndrome Type 2
  • Age 18 years or older
  • Informed written consent given
  • Willingness to comply with study protocol and attend study visits
  • Suitable for treatment with differential target multiplexed spinal cord stimulation as determined by treating physician
Not Eligible

You will not qualify if you...

  • Unable to receive or properly operate the spinal cord stimulation system
  • History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
  • Active cancer
  • Addiction to drugs, alcohol (more than 5 units per day), or medication
  • Active disruptive psychiatric disorder or other condition impacting pain perception or study compliance
  • Immune deficiency such as HIV or immunosuppressive treatment
  • Life expectancy less than 1 year
  • Local infection or skin disorder at incision site
  • Pregnancy
  • Presence of another implanted active medical device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 12 months

Participants receive differential target multiplexed spinal cord stimulation to manage chronic back and leg pain.

Visits at 1 month, 6 months, and 12 months after implantation

Long-term Monitoring

Duration - Up to 12 months following implantation

Participants are monitored for effectiveness, safety, and technical issues related to spinal cord stimulation.

Assessments at 1 month, 6 months, and 12 months after implantation

Trial Site Locations

Total: 14 locations

1

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

2

ZNA

Antwerp, Belgium

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3

AZ Sint-Jan Brugge-Oostende

Bruges, Belgium

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4

AZ Sint-Lucas Brugge

Bruges, Belgium

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5

Jessa Ziekenhuis

Hasselt, Belgium

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6

AZ Groeninge

Kortrijk, Belgium

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7

UZ Leuven

Leuven, Belgium

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8

Heilig Hart Ziekenhuis Lier

Lier, Belgium

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9

Centre Hospitalier Régional (CHR) de la Citadelle

Liège, Belgium

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10

AZ Sint-Maarten

Mechelen, Belgium

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11

AZ Delta

Roeselare, Belgium

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12

Vitaz

Sint-Niklaas, Belgium

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13

AZ Turnhout

Turnhout, Belgium

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14

GZA

Wilrijk, Belgium

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Research Team

M

Maarten Moens, prof.dr.

L

Lisa Goudman, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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).

Lisa Goudman, Ann De Smedt, Sam Eldabe...

https://pubmed.ncbi.nlm.nih.gov/39521475