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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Regional Pain Syndrome Type I
• Intervention / Treatment: Device: 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
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Vincent WYART, MSc; Phone Number: 0240958176; Email: vincent.wyart@elsan.care

Study Locations

• France
  • Nantes, France, 44046
    • Recruiting
    • Clinique Breteche
    • Contact: Clinique BRETECHE; Phone Number: 0251868686

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Burst stimulation; Patients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs

Device: Implantable spinal cord stimulator; Spinal cord stimulation is possible thanks to implantable spinal cord neurostimulators. These are medical devices, which include a stimulation electrode and an implantable box, designed to deliver electrical stimulation for pain relief. The electrode is implanted in the epidural space in order to stimulate the posterior cords of the spinal cord through the dura mater, at the dorsal or cervical level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment at 3 months after implant	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure assesment	By using: - VAS (ranging from 0: "No pain" to 100: "Maximum pain imaginable")	1 month, 3 months, 6 months and 12 months
Assessing attention and working memory	By using: - Trail Making Test (Reitan RM 1958) (2 parts A and B measured in seconds: The maximum score for part A is 100", 101" indicating that the test was not completed. The maximum score for Part B is 300", 301" indicating that the test was not completed)	3 months and 12 months
qualitatively evaluate the effectiveness of the procedure	Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions.	3 months
Medication use	Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used)	1 month, 3 months, 6 months and 12 months
procedure assesment	By using: - Hospital Anxiety and Depression scale (HAD) (Mykletun A 2001) (2 columns ranging from 0 " no or few anxiety" to 21 "high anxiety"	1 month, 3 months, 6 months and 12 months
procedure assesment	By using: - Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good")	1 month, 3 months, 6 months and 12 months
Assessing attention and working memory	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)	3 months and 12 months

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: Abbott
• Investigators: Study Director: Jean-Paul NGUYEN, Prof, Clinique Bretéché ELSAN; Principal Investigator: Sylvain DURAND, Dr, Clinique Bretéché ELSAN

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 2023-A00638-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No