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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2027-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Percutaneous Electrical Nerve Stimulation Compared to Passive Assisted Neurodynamics in Brachial Plexus Neuropathy

NCT05432973

Percutaneous Electrical Nerve Stimulation Peripheral Neuropathy Neuropathic Pain

UNKNOWN NA

Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade

NCT03653000

Nerve Block

UNKNOWN NA

Description of the Brachial Plexus Block at the Humeral Head in Children: a Sono-anatomical Study

NCT06158243

Anesthesia, Local Brachial Plexus; Pressure

NOT_YET_RECRUITING

The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction

NCT01716078

Anesthesia

WITHDRAWN

The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block

NCT06130514

Chronic Pain Neuropathic Pain Complex Regional Pain Syndromes +2 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuralgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomisation at month 1

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BP PNS (experimental group)

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

Group Type EXPERIMENTAL

electrical stimulation of the brachial plexus nerve roots

Intervention Type DEVICE

treated by chronic electrical stimulation of the brachial plexus nerve roots

sham stimulation (control group).

Patients with refractory upper limb neuropathic pain treated by sham stimulation

Group Type ACTIVE_COMPARATOR

sham stimulation

Intervention Type OTHER

treated by sham stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

electrical stimulation of the brachial plexus nerve roots

treated by chronic electrical stimulation of the brachial plexus nerve roots

Intervention Type DEVICE

sham stimulation

treated by sham stimulation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Months

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No