Actively Recruiting
Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-19
48
Participants Needed
3
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligibility confirmed by trained clinicians with expertise in chronic and neuropathic pain
- Age between 18 and 80 years old
- Moderate to severe chronic neuropathic pain (VAS score >5/10) lasting more than 12 months
- Pain located in one upper limb
- Neuropathic pain of peripheral origin, including complex regional pain syndrome types I and II, post-traumatic or post-surgical pain
- Pain resistant to first and second line neuropathic pain treatments according to French guidelines, including specific antidepressants, gabapentin, pregabalin, tricyclic antidepressants, topical treatments, psychotherapy, or combinations
- Signed informed consent
- Beneficiary of the French social insurance system
You will not qualify if you...
- Brachial plexus avulsion
- Post-zoster neuropathic pain
- Phantom limb pain
- Unable to complete self-administered questionnaires
- Chronic disease requiring repeated MRI monitoring
- Contraindications to general anesthesia, surgery, or percutaneous brachial plexus approach
- Presence of cardiac pacemakers, defibrillators, or high risk for defibrillator use due to cardiac disorders
- Unstable neuropsychological or psychiatric disorders
- Vulnerable participants: pregnant or breastfeeding, minors, adults under guardianship, or deprived of freedom
AI-Screening
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Trial Site Locations
Total: 3 locations
1
CHU de Lyon
Lyon, France, France, 69500
Actively Recruiting
2
CHU de Nice
Nice, France, France, 06000
Actively Recruiting
3
CHU de Poitiers
Poitiers, France, France, 86 0214
Actively Recruiting
Research Team
D
DENYS FONTAINE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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