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Tests treatment safety and results for Chronic Neuropathic Pain
Official title Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain
ClinicalTrials.gov ID: NCT07154056
What this study is testing
- What it's testing
- The goal of the study is to demonstrate Spinal Transforaminal NeuroStimulation effectiveness with FAST and other waveforms / combinations to relief neuropathic peripheral pain in chronic neuropathic pain patients, at low risk and low energy consumption.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
See the full eligibility 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-
- 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 treatment 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...
- people requiring closer protection, i.e. minors, people deprived of their freedom by a court or administrative decision, people admitted to a health or social welfare establishment, major people under legal protection...
- Pregnant or breastfeeding women, women at age to procreate and not using effective contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Poitiers, France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poitiers, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.