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NCT05817786: SIMPLEX

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

Recruiting now NA Last updated 19 March 2025
What this trial tests

NA trial testing electrical stimulation of the brachial plexus nerve roots in Neuralgia in 48 participants. Currently enrolling.

Timeline
9 February 2024
Primary endpoint
9 July 2026
1 July 2027

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Nice
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment48
Start date9 February 2024
Primary completion9 July 2026
Estimated completion1 July 2027
Sites3 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Adults 18 Months to 80, any sex, with Neuralgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Neuralgia

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire de Nice trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05817786.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing