NCT05817786 Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
| NCT ID | NCT05817786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Neuralgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-02-09 |
| Primary Completion | 2026-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-02-09 with a primary completion date of 2026-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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
Contact & Investigator
Denys FONTAINE
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Frequently Asked Questions
Who can join the NCT05817786 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 80 Years, studying Neuralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05817786 currently recruiting?
Yes, NCT05817786 is actively recruiting participants. Contact the research team at fontaine.D@chu-nice.fr for enrollment information.
Where is the NCT05817786 trial being conducted?
This trial is being conducted at Lyon, France, Nice, France, Poitiers, France.
Who is sponsoring the NCT05817786 clinical trial?
NCT05817786 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Denys FONTAINE at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 48 participants.