Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs (STIMBURST)

Elsan

Status

Enrolling

Conditions

Complex Regional Pain Syndrome Type I

Treatments

Device: Implantable spinal cord stimulator

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05877612

2023-A00638-37

Details and patient eligibility

About

In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.

Full description

There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.

There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.

The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.

In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients between 18 and 75 years of age
Patient with CRPS of at least one upper limb
Patient affiliated to a Social Security plan
Patient who has signed and dated the no-objection form
Patient with the cognitive ability to understand the treatment and complete the questionnaires
Patient who can be followed for a minimum of 1 year

Exclusion criteria

Patient with an uncontrolled infection
Pregnant or breastfeeding patient
Patient who has already undergone treatment by spinal cord stimulation
Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
Patient who cannot be followed regularly for psychological, social, family or geographical reasons
Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.