Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT07154056
Eligibility Criteria:
Inclusion Criteria:
* Subject has ≥ 18 years and ≤ 80 years
* Subject has a global Visual Analogic Scale ≥ 5
* Subject has non-cancer pain with a significant neuropathic component for at least 6 months.
* Subject has stable pain for at least 30 days
* Pain medication(s) dosage(s) is/are stable for at least 30 days
* Subject is eligible for Spinal Transforaminal NeuroStimulation after a pre-implantation assessment by a multidisciplinary team, as described by the French National Authority for Health (Haute Autorité de Santé)
* Subject understands and accepts the constraints of the study and is able to use the equipment.
* Patient is covered by French national health insurance.
* Subject has given written consent to the study after having received clear and complete information.
Non-inclusion Criteria:
* Subject has a coagulation disorder
* Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system
* Subject has had corticosteroid therapy within the past 30 days
* Subject has had radiofrequency therapy within the past 3 months
* Subject has been diagnosed with cancer in the past 2 years
* Subject has had a spinal surgery within the past 6 months
* Simultaneous participation to any interventional study on health product or any study able to interfere with the current study endpoints.
* Subject has at least one of brain MRI contraindications such as : intracranial clips /Vascular clips/Pace maker/Heart battery, Defibrillator, Implanted Holter (REVEAL type), Neuro-stimulator not compatible with 1.5 T MRI/Stents/ Coils/Cardiac valves (heart)/ Shunt valve/Implanted injection pump/Cochlear implants/Implantable chamber (PAC)/Intracorporeal metal shards/ metallic foreign bodies, the location and the presence of implanted neurostimulation components that are not listed as MRI Conditional, cardiac implantable electronic device, metallic intraocular foreign bodies, cochlear implants, drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid, piercing.
* Subjects requiring closer protection, i.e. minors, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting
* Pregnant or breastfeeding women, women at age to procreate and not using effective contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07154056
Study Brief:
Protocol Section:
NCT07154056