RecruitingNot ApplicableNCT05817786

Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots


Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

48 participants

Start Date

Feb 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 MonthsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests electrical stimulation of the brachial plexus nerve roots — a surgical implant procedure — for adults with severe, treatment-resistant chronic neuropathic pain in one arm. Neuropathic pain in the arm can result from surgery, trauma, nerve injuries, or complex regional pain syndrome, and when conventional medications and therapies fail, patients are left with few options. By delivering small electrical pulses directly to the nerve roots at the spinal level, neuromodulation aims to interfere with pain signaling at its source. Eligible participants are adults between 18 and 80 with severe (pain score above 5 out of 10), chronic (more than 12 months), neuropathic arm pain that has not responded to multiple established treatments including antidepressants, gabapentin, pregabalin, and topical agents. Patients with brachial plexus avulsion, phantom limb pain, cardiac pacemakers, unstable psychiatric disorders, or who are pregnant are excluded. Participants undergo surgical implantation of the stimulator and are followed for pain relief, quality of life, and safety. For patients with refractory neuropathic arm pain, life can be utterly dominated by pain. This study offers hope for a population that has exhausted conventional options, and could establish brachial plexus stimulation as a viable, minimally invasive neurosurgical alternative that gives people their lives back.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEelectrical stimulation of the brachial plexus nerve roots

treated by chronic electrical stimulation of the brachial plexus nerve roots

OTHERsham stimulation

treated by sham stimulation


Locations(3)

CHU de Lyon

Lyon, France, France

CHU de Nice

Nice, France, France

CHU de Poitiers

Poitiers, France, France

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NCT05817786


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