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

NCT05712980 | Unknown FDA Device

• 1 other identifier: SCS - OMICS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; spinal cord stimulation; RNAseq; DTM; transcriptomics; omics; failed back surgery syndrome

Outcome Measures

Primary Outcomes (1)

• Transcriptomic profile change in DTM responders

  Identify the transcriptomic signature of responding patients undergoing DTM programming of the SCS system and analyze potential changes over time

  T0: Before IPG; T1: 15 days after IPG and T2 2 months after IPG

Secondary Outcomes (5)

• DTM vs Conventional signatures

  T0: Before IPG; T1: 15 days after IPG and T2 2 months after IPG

• Transcriptomic Profile vs Clinical Outcomes

  T0: Before IPG; T1: 15 days after IPG and T2 2 months after IPG

• Intensity of pain

  T0: Before IPG; T1: 15 days after IPG and T2 2 months after IPG

• QOL

  T0: Before IPG; T1: 15 days after IPG and T2 2 months after IPG

• Level of disability

  T0: Before IPG; T1: 15 days after IPG and T2 2 months after IPG

Study Arms (2)

DTM Cohort

Patients with Failed Back Surgery Syndrome treated with Spinal Cord Stimulation with DTM programming

Device: Implanted pulse generator for SCS with different programming modalities

Conventional Cohort

Patients with Failed Back Surgery Syndrome treated with Spinal Cord Stimulation with conventional programming

Device: Implanted pulse generator for SCS with different programming modalities

Interventions

Implanted pulse generator for SCS with different programming modalities DEVICE

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

Conventional Cohort; DTM Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by FBSS fullfilling all the inclusion and none of the exclusion criteria will be included. Following our usual protocol, all patients will attend a session with our psychologist to consider the adequacy of the treatment to be used and to determine the effect of psychosocial issues on their pain complaints. A negative evaluation will be considered a key exclusion criterion. Patients will be instructed to keep their medication dosage stable throughout the study. All the subjects of study will be implanted with the same device from Medtronic. The device will be programmed with two different strategies, the conventional one and the Differential Targeted Multiplexed (DTM) programming.

You may qualify if:

• Adult patients affected by FBSS, defined as "surgical end stage after one or several interventions on the lumbar neuroaxis indicated to relief lower back pain, root pain or the combination of both, without effect"
• Age between 18 and 65 years
• Severe pain measured on a numerical rating scale (NRS \> 6/10), more than six months of evolution
• Refractory pain despite having carried out pharmacological treatment according to WHO's stratified approach; physical/rehabilitation therapy and/or interventional procedures (e.g. epidural steroid injections, radiofrequency, epiduroscopy/adhesiolysis)

You may not qualify if:

• Patients with severe associated comorbidities (e.g. severe high blood pressure, diabetes mellitus, peripheral vasculopathy, severe heart disease, etc...) that may in themselves cause pain or aggravate the existence of previous pain.
• Extensive osteosynthesis encompassing the thoraco-lumbar region where the tips of the electrodes are routinely positioned.
• Abnormal pain behavior, unresolved psychiatric illness, unresolved issues of secondary gain or inappropriate medication use
• Patients not consenting or refusing to participate will be excluded
• Negative evaluation of the psychologist previous to the implant

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead

Study Sites (1)

Consorcio Hospital General Universitario

Valencia, 46014, Spain

Location

Related Publications (32)

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MeSH Terms

Conditions

Failed Back Surgery Syndrome; Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gustavo Fabregat, MD, PhD

  Consultant of Anesthesiology and Pain Medicine Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Fabregat, MD, PhD

CONTACT

+34963131800; gfabregat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Anesthesiology and Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 6, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)