Clinical Decision Support System (CDSS) in Neurostimulation Therapy

NCT04735159 | Completed DMC

• 1 other identifier: Biomarcadores-RM
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic pain is correlated with alterations in the structure and function of the brain, developed according to the phenotype of pain. Still today, the data on functional connectivity (FC), on chronic back pain, in patients with failed back surgery syndrome (FBSS), is limited. The selection process for the ideal candidate for spinal cord stimulation (SCS) is based on results from test and functional variables analysis as well as pain evaluation. In addition to the difficulties in the initial selection of patients and the predictive analysis of the test phase, which undoubtedly impact on the results in the middle and long term, the rate of explants is one of the most important concerns, in the analysis of suitability of implanted candidates. The hypothesis is that the structural and functional quantitative information provided by imaging biomarkers will improve the characterization of the patients compared to the characterization with the current clinical variables alone and this will allow establishing a CDSS that improve the effectiveness of the SCS implantation, optimizing human, economic and psychological resources. A prospective, consecutive and observational, open-label, single-center study conducted at the Multidisciplinary Pain Management Department of our University Hospital. A total of 69 subjects were initially included in the study. The population split in 3 groups:

• Interventional Group-SCS, included 35 patients with failed back surgery syndrome (FBSS) who were treated with SCS implants.
• Comparator group included 23 patients with patients with chronic low-back pain who were treated with conventional medication (CM) for their pain.
• Control Group included 11 subjects as health controls who volunteered to participate in the study. MR images were obtained in a 1.5T MR system (Ingenia, Philips, Best, The Netherlands) using an 8-channel head coil.Clinical variables were evaluated at two different time points baseline and 12 months after SCS implantation or conventional medication. An ad hoc database was created to evaluate the different variables involved in pain , including sociodemographic variables (age, gender, level of studies and marital status), clinical variables (anxiety, depression, sleeping hours, resilience, NRS, the Pain Detect Questionnaire (PD-Q)) , and the images obtained from the fMRI.

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical decision support system (CDSS) for selection of patients candidates for SCS implant

  to analyze the neuronal circuits involved in FBSS patients in order to extract predictive imaging biomarkers capable of determining the characteristics of patients that predict the success of SCS implants. This information might be used to develop a CDSS to maximize the effectiveness of electrical stimulation devices surgically implanted in patients with chronic pain.

  12 months

Secondary Outcomes (1)

• neuronal circuits involved in chronic pain

  12 months

Study Arms (3)

Study group-SCS Impanted

ACTIVE COMPARATOR

30 patients with chronic pain (at least 6 months) with pre- and post-surgery evaluation (imaging and clinical evaluation) implanted with Precision SpectraTM for the validation study and for the construction of the predictive model.

Device: SCS implanted with Precision SpectraTM

Comparator-chronic pain

NO INTERVENTION

20 patients with chronic pain (at least 6 months) with degenerative spine pain. Non-specific low-back pain, nociceptive pain / mixed neuropathic. This will be the comparator group

Control-healthy volunteers

NO INTERVENTION

10 volunteers without pain or related disease, age less than 25 years, to establish a control group whose pattern is used as a comparator with chronic pain groups. This is the control group

Interventions

SCS implanted with Precision SpectraTM DEVICE

Analyze the relationship between neuroimaging biomarkers and the different clinical scales and variables captured from each patient

Also known as: Functional Magnetic Resonance performed after implating SCS

Study group-SCS Impanted

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting pain of more than 6 months in duration
• VAS Score at baseline ≥ 5
• Patients with degenerative spine pain. Non specific low-back pain, nociceptive pain / mixed neuropathic
• Post-operative spine pain, failed back surgery syndrome, mixed pain
• Low consumption of analgesic and adjuvant drugs.
• Pure radiculopathy
• No suffering other serious chronic diseases.
• No history of drug or alcohol.

You may not qualify if:

• Having implanted pacemakers, stimulators or hearing aids incompatible with MR imaging.
• Patients presenting psychiatric illness or significant cognitive deficits.
• Psychological instability.
• History of alcohol and drugs.
• Severe coagulopathy.
• Pending Surgery.

Sponsors & Collaborators

• General University Hospital of Valencia: lead
• Boston Scientific Corporation: collaborator

Related Publications (29)

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MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Professor of Anesthesiology, Valencia University Medical School. Chairman of the Department of Anesthesiology Critical Care and Pain Management. General University Hospital. Valencia (Spain)

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 3, 2021
• Study Start: November 20, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02