Clinical trial NCT05877612: Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs
Official title: Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complex Regional Pain Syndrome Type I
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2023-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs, eligible for implantation of a medullary stimulator

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain assessment at 3 months after implant
timeFrame: 3 months
Secondary outcomes:
measure: procedure assesment
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: Assessing attention and working memory
timeFrame: 3 months and 12 months
measure: qualitatively evaluate the effectiveness of the procedure
timeFrame: 3 months
measure: Medication use
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: procedure assesment
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: procedure assesment
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: Assessing attention and working memory
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Clinique BRETECHE
Study officials:
affiliation: Clinique Bretéché ELSAN
name: Jean-Paul NGUYEN, Prof
role: STUDY_DIRECTOR
affiliation: Clinique Bretéché ELSAN
name: Sylvain DURAND, Dr
role: PRINCIPAL_INVESTIGATOR
References: