Clinical Decision Support System (CDSS) in Neurostimulation Therapy
CompletedNot applicableNCT04735159
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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…
Study details
- Official title
- Development of a Predictive Model of Effectiveness for the Implantation of Electrical Neurostimulators in Patients With Chronic Pain Using Imaging Biomarkers Extracted From Magnetic Resonance
- Conditions
- Interventions
- Device: SCS implanted with Precision SpectraTM
- Sponsor
- General University Hospital of Valencia
- Collaborators
- Boston Scientific Corporation
- Start date
- 2016-11-20
- Primary completion
- 2018-06-30
- Sex
- All
- Age range
- from 20 Years to 80 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04735159