MedTrace Logo

Transcriptomic Profile of Patients Treated With Different Modalities of Spinal Cord Stimulation

NCT05712980 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-02-06

No results posted yet for this study

Summary

Failed Back Surgery Syndrome (FBSS) is a relatively common condition that can cause a severe disability in patients. Spinal cord stimulation (SCS) is used in those patients refractory to conventional therapies.In this project the investigators aim to identify new functional molecular basis, defined with transcriptomic profiling, differentially represented in the serum of patients suffering chronic pain caused by FBSS.

The investigators will try to Identify "omics" markers for diagnosing and monitoring the process of development and maintenance of pain as well as the evaluation of these as evolutionary disease markers or predictors of the response to SCS therapy. To carry out the project, 40 patients diagnosed with refractory FBSS and treated with an SCS system for pain management will be included. Blood samples will be obtained to analyze the transcription profiling in plasma of patients responding to different modalities of SCS therapy.

Conditions

  • Spinal Cord Stimulation
  • Failed Back Surgery Syndrome
  • Genetic Change

Interventions

DEVICE

Implanted pulse generator for SCS with different programming modalities

Surgical technique Patients recruited will be scheduled for the implantation of the SCS system in two phases. The implant procedure will be performed following our standardized clinical practice under local anesthesia and moderate sedation. Clinical parameters Clinical evaluation of study subjects shall include, in addition to demographic parameters, the assessment of parameters related to pain experience, disability, quality of life, as well as other psychological variables. All these parameters will be evaluated at different times of the study. Sample processing 10 ml of peripheral blood will be obtained per venopuncture at different moments, always at the same time of day and in the same anatomical location. Expression arrays After a manual removal of RNA the expression arrays and the scanning of the crystals will be carried out after hybridization

Sponsors & Collaborators

  • Hospital General Universitario de Valencia

    lead OTHER

Principal Investigators

  • Gustavo Fabregat, MD, PhD · Consultant of Anesthesiology and Pain Medicine Department

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-02-28
Completion
2025-09-30
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712980 on ClinicalTrials.gov