NCT05877612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

May 5, 2023

Last Update Submit

October 10, 2023

Conditions

Complex Regional Pain Syndrome Type I

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • procedure assesment

    1 month, 3 months, 6 months and 12 months

  • Assessing attention and working memory

    3 months and 12 months

  • qualitatively evaluate the effectiveness of the procedure

    3 months

  • Medication use

    1 month, 3 months, 6 months and 12 months

  • procedure assesment

    1 month, 3 months, 6 months and 12 months

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

Implantable spinal cord stimulatorDEVICE

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.

Burst stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs, eligible for implantation of a medullary stimulator

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique BRETECHE

Nantes, 44046, France

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Jean-Paul NGUYEN, Prof

    Clinique Bretéché ELSAN

    STUDY DIRECTOR

  • Sylvain DURAND, Dr

    Clinique Bretéché ELSAN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent WYART, MSc

CONTACT

0240958176vincent.wyart@elsan.care

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 26, 2023

Study Start

September 12, 2023

Primary Completion

December 1, 2024

Study Completion

September 1, 2025

Last Updated

October 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)