Differential Target Multiplexed Spinal Cord Stimulation (DETECT)

Moens Maarten

Status

Enrolling

Conditions

Persistent Spinal Pain Syndrome Type 2

Failed Back Surgery Syndrome

Treatments

Device: Spinal Cord Stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT05068011

DETECT

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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