Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead(s) implantation, 7days trial phase, Implantable Pulse Generator implantation | Experimental | One or two 8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. This will be followed by a trial phase for a period of 7 days in order to assess the benefits of stimulation. Patients who succeeded the trial phase (at least 30% reduction of leg pain measured with a 5-day pain diary) will be implanted with a permanent system (Implantable Pulse Generator). At first, all patients will be programmed under FAST stimulation for at least 24h to fully perceive its efficacy. If the patient is satisfied with FAST then the patient will continue with this program but if the patient is not satisfied, then the patient could switch to other waveforms that will be pre-programmed during the visit including conventional and microburst stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lead(s) and Implantable Pulse Generator implantation | Device | 8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. Awake anesthesia will allow patients to be tested during the surgery in order to determine the sweet spot and the optimal paresthesia coverage using the PREDI-P platform for a single lead. A trial phase will be performed for a period of 7 days in order to assess the benefits of stimulation according to the HAS (French Health Authority) guidelines. Subjects who succeed the lead trial will receive a permanent implant depending on the patient electrical consumption during the lead trial period or according to the implanter decision. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index. | The Multidimensional Clinical Response Indexwas previously developed and validated to evaluate the pain-related health state of PSPS-T2 patients. This weighted composite outcome includes pain intensity, functional disability, quality of life, psychological distress and pain mapping surface. The Multidimensional Clinical Response Indexis a score that ranges from 0 (worst pain-related health status) to 10 (best pain-related health status). The score has been used in several studies evaluating efficacy of different neurostimulation modalities. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in pain intensity between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. | Will be used : Pain Visual Analogic Scale (VAS). Pain intensity is measured on a 0-10 scale (0 = no pain ; 10 = worst possible pain). | 6 months |
| Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation. |
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Rigoard, MD, PhD | Contact | +33549443548 | philippe.rigoard@chu-poitiers.fr | |
| Manuel ROULAUD, MS, PhD | Contact | +33549443223 | manuel.roulaud@chu-poitiers.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poitiers University Hospital | Recruiting | Poitiers | France | 86000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Patient satisfaction will be assessed using patient Global Impression of Change questionnaire (PGIC). |
| 6 months |
| To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms. | Evaluation of intensity of each symptom (numbness, burning sensation, tingling, allodynia, electric shock, hypoesthesia) using the PainDetect questionnaire. | 6 months |
| Surface (cm²) of each symptom calculated using the Pain mapping software. | To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms. | 6 months |
| To characterize the Spinal Transforaminal NeuroStimulation neural targeting based on 3D-imaging and electrophysiological exploration in order to precisely identify the optimal paresthesia-based neural target locations. | Imaging data (3D-MRI and CT fusion) pre-operatively to identify the ganglion position related to the foramen at baseline. For electrophysiological data, we will collect lead performance and selectivity for each program used by the patient under paresthesia-based stimulation at 1-, 3- and 6-month follow-ups. | 6 months |
| Rate of serious and non-serious adverse events and device deficiencies will be reported. | 6 months |
| Rate of patients undergoing FAST stimulation (exclusively or in combination with other waveforms) at 6-month follow-up. | 6 months |
| Mean absolute change in Multidimensional Clinical Response Index for the subgroup of patients undergoing FAST at 1-, 3- and 6-month follow-ups. | 6 months |
| Absolute change in pain surface between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. | Pain surface will be assessed using the surface of the painful zone (cm²) measured using the pain mapping software. | 6 months |
| Absolute change in health related quality of life between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. | Health related quality of life will be assessed using EuroQuol 5 Dimensions 5 levels (EQ5D 5L) index (-0.53 to 1 score ; 1 = full health and 0 = a state as bad as being dead). | 6 months |
| Absolute change in functional disability between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. | Functional disability will be assessed using the Oswestry Disability Index (ODI) (0 to 100 score with 0-20 = minimal disability, 21-40 = moderate disability, 41-60 = severe disability, 61-80 = cripple, pain impinges on all aspects of patient's life, 81-100 = patients are bed-bound or exaggerating their symptoms). | 6 months |
| Absolute change in anxiety and depression between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. | Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety and depression scores. | 6 months |
| Evaluation of energy consumption at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation. | Energy consumption will be calculated as the delivered electric current (µC per second). | 6 months |