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
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of electrical stimulation of the brachial plexus nerve roots to treat moderate to severe chronic neuropathic pain in the upper limb. This condition affects about 5% of the French population, with nearly half experiencing pain in the upper limb. Current invasive treatments like spinal cord stimulation have limitations, prompting this study to evaluate the effects of brachial plexus peripheral nerve stimulation (BP PNS) in controlled conditions for pain relief, quality of life improvement, and safety. The study compares two groups: one receiving chronic electrical stimulation of the brachial plexus nerve roots using implanted devices, and another receiving sham stimulation. The implantation uses an ultrasound-guided percutaneous approach, similar to techniques used for anesthetic nerve blocks. Participants undergo treatment for at least three months to assess efficacy and safety. Participants will be adults aged 18 to 80 years with unilateral moderate to severe neuropathic pain unresponsive to standard treatments. Researchers will monitor pain levels, quality of life, and any side effects during the study. The main outcome measured is the effectiveness of the treatment after three months. Participants will complete questionnaires and be closely followed to assess the treatment impact and safety throughout the trial.
CONDITIONS
Brief 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 determined by clinicians expert in chronic and neuropathic pain
- Age between 18 and 80 years
- Moderate to severe chronic neuropathic pain (VAS score >5/10) lasting more than 12 months
- Pain located in one upper limb of peripheral origin, including complex regional pain syndrome type I and II, post-traumatic or post-surgical pain
- Refractory to first and second line neuropathic pain treatments including SNRIs, gabapentin, pregabalin, tricyclic antidepressants, topical lidocaine, capsaicin patches, psychotherapy, or combinations
- Signed informed consent
- Benefiting from French social insurance system
You will not qualify if you...
- Brachial plexus avulsion
- Post-zoster neuropathic pain
- Phantom limb pain
- Inability to complete self-administered questionnaires
- Chronic diseases requiring repeated MRI monitoring
- Contraindications to general anesthesia, surgery, or percutaneous brachial plexus approach
- Presence of other pacemakers or high risk for defibrillator use due to cardiac disorders
- Unstable neuropsychological or psychiatric disorders
- Vulnerable patients: pregnant or breastfeeding, minors, adults under guardianship, or deprived of freedom
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the device for chronic electrical stimulation of the brachial plexus nerve roots or receive sham stimulation.
1 visit (in-person)
Duration - 3 months
Participants receive chronic electrical stimulation of the brachial plexus nerve roots or sham stimulation to treat upper limb chronic neuropathic pain.
Regular visits during treatment period
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
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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