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NCT Number: NCT05817786

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

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.

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Key information

Age range

18 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Lyon, Lyon, France

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About this study

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. However, SCS implanted at the cervical level, required to control UL pain, has shown its efficacy but has specific technical issues that limit its use: lead dislocation or breakage (0-43%), lead migration (0-12,5%), unwanted paresthesias in the trunk or the lower limb(s) (17%), paresthesias changes during head movements (48%). To avoid these limitations, peripheral nerve stimulation (PNS) targeting the UL nerve trunks or nerve roots of the brachial plexus (BP) has been proposed in short pioneering series reporting encouraging results .

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).

In a recent prospective series of 26 patients suffering from UL refractory pain, we reported that 20 patients still using the stimulation at last follow-up (28 months) experienced a mean pain relief of 67%. Seventeen patients were improved ≥50%, including 12 improved ≥70%. Complications were rare: stimulation intolerance due to shock-like sensations, superficial infection, lead fractures and lead migration . 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrical stimulation of the brachial plexus nerve roots

Device

treated by chronic electrical stimulation of the brachial plexus nerve roots

Sham stimulation

Other

treated by sham stimulation

Primary outcomes

  1. efficacity

    Time frame: after 3 months of treatment

    evaluation by the patient with quizz EQ5D (worse: 0-better: 20)

  2. efficacity

    Time frame: after 3 months of treatment

    evaluation by the patient with quizz VAS (worse: 0- better: 100)

Study contacts

Contact information is provided by the study sponsor or research team.

DENYS FONTAINE

CONTACT

[email protected]

0492034702

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: SIMPLEX

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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