NeuralgiaSIMPLEXNCT05817786
Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
A study testing electrical stimulation of the brachial plexus nerve roots in people with Neuralgia, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
Moderate to severe neuropathic pain has a prevalence of 5% in the French population, involving the upper limb (UL) in 47%. Invasive neuromodulation, mainly spinal cord stimulation (SCS) is recommended as a third line treatment in refractory chronic neuropathic pain when optimized medical treatments are not sufficient… Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Neuralgia
- What is being tested?
- electrical stimulation of the brachial plexus nerve roots
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Feb 2024to 1 Jul 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 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligibility will be determined by trained clinicians with expertise in chronic pain and neuropathic pain.
- Patients between 18 and 80 years old
- suffering from moderate to severe (VAS score >5/10) chronic (duration> 12 months) neuropathic (DN4 score ≥ 4/10) unilateral pain - located in the upper limb.
- from peripheral origin, including complex regional pain syndrome type I and II, post-traumatic or post surgical pain.
- refractory to first and second line treatments for neuropathic pain according recent French recommendations and guidelines[6], including serotonin- noradrenaline reuptake inhibitor (SNRI) antidepressants (duloxetine and venlafaxine), gabapentin, pregabalin, tricyclic antidepressants, topical lidocaine, high-concentration capsaicin patches, psychotherapy and combinations of them.
- Patient have signed informed consent
- Patient benefiting from French social insurance system
Who cannot join
- Brachial plexus avulsion
- Post-zoster neuropathic pain
- Phantom limb pain
- Patient unable to fill a self-administered questionnaire
- Patients with a chronic disease requiring repeated MRI monitoring
- Patients with contra-indication to general anesthesia, surgery or percutaneous BP approach.
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- Patients with other pacemakers (cardiac pacemaker or defibrillator) or patients with a high risk to use a defibrillator due to a known cardiac disorder.
- Patients with instable neuropsychological or psychiatric disorders
- Vulnerable patients: pregnant or breast feeding, minor, adult under guardianship or deprived freedom
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Lyon
Lyon, France, 69500
Patrick MERTENS
Manon DURAFFOURG
- Recruiting
CHU de Nice
Nice, France, 06000
Denys FONTAINE
- Recruiting
CHU de Poitiers
Poitiers, France, 86 0214
Philippe RIGOARD
Bénédicte BOUCHE
About this study
Moderate to severe neuropathic pain has a prevalence of 5% in the French population, involving the upper limb (UL) in 47%. Invasive neuromodulation, mainly spinal cord stimulation (SCS) is recommended as a third line treatment in refractory chronic neuropathic pain when optimized medical treatments are not sufficient to control pain.
The implantation technique for BP roots PNS is based on the ultrasound-guided percutaneous inter-scalenic approach, routinely used for BP anesthetic blocks. As for SCS, BP PNS relies on chronic electrical stimulation of the nerve roots via chronically implanted devices (one lead connected to a subcutaneous generator).
However efficacy of BP PNS has never been evaluated in controlled conditions. Our objectives are to assess, in controlled conditions, the effects of BP PNS in term of pain relief, quality of life improvement and safety.
Read the detailed description
Moderate to severe neuropathic pain has a prevalence of 5% in the French population, involving the upper limb (UL) in 47% . Invasive neuromodulation, mainly spinal cord stimulation (SCS) is recommended as a third line treatment in refractory chronic neuropathic pain when optimized medical treatments are not sufficient to control pain. However, SCS implanted at the cervical level, required to control UL pain, has shown its efficacy but has specific technical issues that limit its use: lead dislocation or breakage (0-43%), lead migration (0-12,5%), unwanted paresthesias in the trunk or the lower limb(s) (17%), paresthesias changes during head movements (48%). To avoid these limitations, peripheral nerve stimulation (PNS) targeting the UL nerve trunks or nerve roots of the brachial plexus (BP) has been proposed in short pioneering series reporting encouraging results .
The implantation technique for BP roots PNS is based on the ultrasound-guided percutaneous inter-scalenic approach, routinely used for BP anesthetic blocks. As for SCS, BP PNS relies on chronic electrical stimulation of the nerve roots via chronically implanted devices (one lead connected to a subcutaneous generator).
In a recent prospective series of 26 patients suffering from UL refractory pain, we reported that 20 patients still using the stimulation at last follow-up (28 months) experienced a mean pain relief of 67%. Seventeen patients were improved ≥50%, including 12 improved ≥70%. Complications were rare: stimulation intolerance due to shock-like sensations, superficial infection, lead fractures and lead migration . However efficacy of BP PNS has never been evaluated in controlled conditions. Our objectives are to assess, in controlled conditions, the effects of BP PNS in term of pain relief, quality of life improvement and safety.
- Conditions
- Neuralgia
- Being tested
- electrical stimulation of the brachial plexus nerve roots, sham stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulation of the brachial plexus nerve rootsDevice
treated by chronic electrical stimulation of the brachial plexus nerve roots
sham stimulationOther
treated by sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| BP PNS (experimental group) | Experimental | Patients with refractory upper limb neuropathic pain treated by chronic electrical stimulation of the brachial plexus nerve roots Receives: Device: electrical stimulation of the brachial plexus nerve roots |
| sham stimulation (control group). | Active comparator | Patients with refractory upper limb neuropathic pain treated by sham stimulation Receives: Other: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacity
evaluation by the patient with quizz EQ5D (worse: 0-better: 20)
Measured: after 3 months of treatment
efficacity
evaluation by the patient with quizz VAS (worse: 0- better: 100)
Measured: after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start9 Feb 2024
- Primary completion9 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomisation at month 1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denys FONTAINE, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817786
- Sponsor's protocol ID
- 20-APN-01
- Other IDs
- 2021-A02538-33
- Acronym
- SIMPLEX
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
- ClinicalTrials.gov ID
- NCT05817786
- Acronym / sponsor ID
- SIMPLEX / 20-APN-01
- Conditions
- Neuralgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Apr 2023 (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.
Moderate to severe neuropathic pain has a prevalence of 5% in the French population, involving the upper limb (UL) in 47%. Invasive neuromodulation, mainly spinal cord stimulation (SCS) is recommended as a third line treatment in refractory chronic neuropathic pain when optimized medical treatments are not sufficient to control pain.
The implantation technique for BP roots PNS is based on the ultrasound-guided percutaneous inter-scalenic approach, routinely used for BP anesthetic blocks. As for SCS, BP PNS relies on chronic electrical stimulation of the nerve roots via chronically implanted devices (one lead connected to a subcutaneous generator).
However efficacy of BP PNS has never been evaluated in controlled conditions. Our objectives are to assess, in controlled conditions, the effects of BP PNS in term of pain relief, quality of life improvement and safety.
Detailed description
Moderate to severe neuropathic pain has a prevalence of 5% in the French population, involving the upper limb (UL) in 47% . Invasive neuromodulation, mainly spinal cord stimulation (SCS) is recommended as a third line treatment in refractory chronic neuropathic pain when optimized medical treatments are not sufficient to control pain. However, SCS implanted at the cervical level, required to control UL pain, has shown its efficacy but has specific technical issues that limit its use: lead dislocation or breakage (0-43%), lead migration (0-12,5%), unwanted paresthesias in the trunk or the lower limb(s) (17%), paresthesias changes during head movements (48%). To avoid these limitations, peripheral nerve stimulation (PNS) targeting the UL nerve trunks or nerve roots of the brachial plexus (BP) has been proposed in short pioneering series reporting encouraging results .
The implantation technique for BP roots PNS is based on the ultrasound-guided percutaneous inter-scalenic approach, routinely used for BP anesthetic blocks. As for SCS, BP PNS relies on chronic electrical stimulation of the nerve roots via chronically implanted devices (one lead connected to a subcutaneous generator).
In a recent prospective series of 26 patients suffering from UL refractory pain, we reported that 20 patients still using the stimulation at last follow-up (28 months) experienced a mean pain relief of 67%. Seventeen patients were improved ≥50%, including 12 improved ≥70%. Complications were rare: stimulation intolerance due to shock-like sensations, superficial infection, lead fractures and lead migration . However efficacy of BP PNS has never been evaluated in controlled conditions. Our objectives are to assess, in controlled conditions, the effects of BP PNS in term of pain relief, quality of life improvement and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomisation at month 1
| Arm | Type | Receives |
|---|---|---|
| BP PNS (experimental group) | Experimental | Device: electrical stimulation of the brachial plexus nerve rootsPatients with refractory upper limb neuropathic pain treated by chronic electrical stimulation of the brachial plexus nerve roots |
| sham stimulation (control group). | Active comparator | Other: sham stimulationPatients with refractory upper limb neuropathic pain treated by sham stimulation |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Eligibility will be determined by trained clinicians with expertise in chronic pain and neuropathic pain.
- Patients between 18 and 80 years old
- suffering from moderate to severe (VAS score >5/10) chronic (duration> 12 months) neuropathic (DN4 score ≥ 4/10) unilateral pain - located in the upper limb.
- from peripheral origin, including complex regional pain syndrome type I and II, post-traumatic or post surgical pain.
- refractory to first and second line treatments for neuropathic pain according recent French recommendations and guidelines[6], including serotonin- noradrenaline reuptake inhibitor (SNRI) antidepressants (duloxetine and venlafaxine), gabapentin, pregabalin, tricyclic antidepressants, topical lidocaine, high-concentration capsaicin patches, psychotherapy and combinations of them.
Key exclusion criteria (9 listed)
- Brachial plexus avulsion
- Post-zoster neuropathic pain
- Phantom limb pain
- Patient unable to fill a self-administered questionnaire
- Patients with a chronic disease requiring repeated MRI monitoring
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 |
|---|---|---|
| electrical stimulation of the brachial plexus nerve rootstreated by chronic electrical stimulation of the brachial plexus nerve roots | Device | BP PNS (experimental group) |
| sham stimulationtreated by sham stimulation | Other | sham stimulation (control group). |
Primary outcome
efficacity
Time frame: after 3 months of treatment
evaluation by the patient with quizz EQ5D (worse: 0-better: 20)
efficacity
Time frame: after 3 months of treatment
evaluation by the patient with quizz VAS (worse: 0- better: 100)
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 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Denys FONTAINE principal investigator
Centre Hospitalier Universitaire de Nice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation of the brachial plexus nerve roots in people with Neuralgia, run by Centre Hospitalier Universitaire de Nice at 3 sites 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 7 inclusion and 9 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 DENYS FONTAINE (0492034702, fontaine.D@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacity (time frame: after 3 months of treatment). The study lists 2 primary outcomes in all. 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 19 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.