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NCT05877612 | RECRUITING | Complex Regional Pain Syndrome Type I

Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs
Sponsor:

Elsan

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.

Condition or disease

Complex Regional Pain Syndrome Type I

Intervention/treatment

Implantable spinal cord stimulator

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 30 participants
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
Actual Study Start Date : 2023-09-12
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs

Location Details

NCT05877612

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Locations

RECRUITING

France,

Breteche clinic

Nantes, France, 44046