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

Recruiting

• Conditions: Complex Regional Pain Syndrome Type I
• Interventions: Device: Implantable spinal cord stimulator

• Registration Number: NCT05877612
• Lead 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.

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 Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-26
• Status Verified: 2023-09
• Study Start: 2023-09-12
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-12
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Burst stimulation	Implantable spinal cord stimulator	Patients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs

Primary Outcome Measures

Name	Time	Method
Pain assessment at 3 months after implant	3 months	The analgesic outcome of spinal cord stimulation will be assessed by comparing the preoperative visual analogue pain scales (VAS) (ranging from 0: "No pain" to 100: "Maximum pain imaginable") to those performed at the 3rd month visit (3 months). Patients with a VAS score of 50% or more improvement will be considered "improved". The VAS value retained corresponds to the average of 3 values taken during the day (morning, noon and evening).

Secondary Outcome Measures

Name	Time	Method
qualitatively evaluate the effectiveness of the procedure	3 months	Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions.
procedure assesment	1 month, 3 months, 6 months and 12 months	By using: - Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good")
Medication use	1 month, 3 months, 6 months and 12 months	Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used)
Assessing attention and working memory	3 months and 12 months	By using: - WAIS-IV (Benson N 2010) ( 4 subtests submited with 10 items in all (ranging 0 to 19 each), to calculate intelligence quotient with a minimum at 0 and a maximum at 190)

Trial Locations

Locations (1)

Clinique BRETECHE; 🇫🇷 Nantes, France