Chronic Neuropathic PainFORASTIMNCT07154056
Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain
A study testing Lead(s) and Implantable Pulse Generator implantation in people with Chronic Neuropathic Pain, run by Poitiers University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Neuropathic Pain
- What is being tested?
- Lead(s) and Implantable Pulse Generator implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2026to 10 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 20Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Poitiers University Hospital
Poitiers, France, 86000
Philippe Rigoard, MD, PhD, +33549443548, philippe.rigoard@chu-poitiers.fr
Manuel ROULAUD, MS, PhD, manuel.roulaud@chu-poitiers.fr
About this study
Official title: Prospective, Longitudinal, Single-arm Interventional Study Evaluating the Efficacy of Spinal Transforaminal NeuroStimulation (STNS) With FAST and MULTIWAVE Stimulation in Patients With Refractory Chronic Neuropathic Pain
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.
- Conditions
- Chronic Neuropathic Pain
- Being tested
- Lead(s) and Implantable Pulse Generator implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lead(s) and Implantable Pulse Generator implantationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lead(s) and Implantable Pulse Generator implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (13)
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).
Measured: 6 months
Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.
Patient satisfaction will be assessed using patient Global Impression of Change questionnaire (PGIC).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Rate of serious and non-serious adverse events and device deficiencies will be reported.
Measured: 6 months
Rate of patients undergoing FAST stimulation (exclusively or in combination with other waveforms) at 6-month follow-up.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start10 Feb 2026
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154056
- Sponsor's protocol ID
- 2025-A00462-47
- Acronym
- FORASTIM
- Status last verified
- Feb 2026
- First submitted
- 16 Jul 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Longitudinal, Single-arm Interventional Study Evaluating the Efficacy of Spinal Transforaminal NeuroStimulation (STNS) With FAST and MULTIWAVE Stimulation in Patients With Refractory Chronic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07154056
- Acronym / sponsor ID
- FORASTIM / 2025-A00462-47
- Conditions
- Chronic Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lead(s) implantation, 7days trial phase, Implantable Pulse Generator implantation | Experimental | Device: Lead(s) and Implantable Pulse Generator implantationOne 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lead(s) and Implantable Pulse Generator implantation8-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. | Device | Lead(s) implantation, 7days trial phase, Implantable Pulse Generator implantation |
Primary outcome
The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index.
Time frame: 6 months
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.
13 secondary outcomes
Absolute change in pain intensity between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.
Time frame: 6 months
Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.
Time frame: 6 months
To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms.
Time frame: 6 months
Surface (cm²) of each symptom calculated using the Pain mapping software.
Time frame: 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.
Time frame: 6 months
Rate of serious and non-serious adverse events and device deficiencies will be reported.
Time frame: 6 months
Rate of patients undergoing FAST stimulation (exclusively or in combination with other waveforms) at 6-month follow-up.
Time frame: 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.
Time frame: 6 months
Absolute change in pain surface between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.
Time frame: 6 months
Absolute change in health related quality of life between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.
Time frame: 6 months
Absolute change in functional disability between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.
Time frame: 6 months
Absolute change in anxiety and depression between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.
Time frame: 6 months
Evaluation of energy consumption at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lead(s) and Implantable Pulse Generator implantation in people with Chronic Neuropathic Pain, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Rigoard, MD, PhD (+33549443548, philippe.rigoard@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.