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

NCT05817786 | Recruiting

• 2 other identifiers: 20-APN-012021-A02538-33
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neuralgia

Outcome Measures

Primary Outcomes (2)

• efficacity

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

  after 3 months of treatment

• efficacity

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

  after 3 months of treatment

Study Arms (2)

BP PNS (experimental group)

EXPERIMENTAL

Patients with refractory upper limb neuropathic pain treated by chronic electrical stimulation of the brachial plexus nerve roots

Device: electrical stimulation of the brachial plexus nerve roots

sham stimulation (control group).

ACTIVE COMPARATOR

Patients with refractory upper limb neuropathic pain treated by sham stimulation

Other: sham stimulation

Interventions

electrical stimulation of the brachial plexus nerve roots DEVICE

treated by chronic electrical stimulation of the brachial plexus nerve roots

BP PNS (experimental group)

sham stimulation OTHER

treated by sham stimulation

sham stimulation (control group).

Eligibility Criteria

• Age: 18 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

CHU de Lyon

Lyon, France, 69500, France

RECRUITING

CHU de Nice

Nice, France, 06000, France

RECRUITING

CHU de Poitiers

Poitiers, France, 86 0214, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denys FONTAINE

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DENYS FONTAINE

CONTACT

0492034702; fontaine.D@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomisation at month 1

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 18, 2023
• Study Start: February 9, 2024
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)