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Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 1, 2026 → Dec 1, 2026
See other at-risk trials from G. d'Annunzio University

Record History

  1. Notable Start date: May 1, 2026 to Sep 1, 2026
    • Primary completion pushed from Jul 1, 2026 to Dec 1, 2026
    • Study completion pushed from Jul 1, 2026 to Mar 1, 2027
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rationale: Chronic Low Back Pain (CLBP) is often associated with "cortical reorganization," where the brain's map of the back becomes less precise. This phenomenon contributes to the persistence of pain and reduced body awareness. While traditional rehabilitation focuses on the physical structure of the spine, neurocognitive approaches use "perceptive surfaces" to provide specific tactile and proprioceptive feedback, aiming to "retrain" the brain's representation of the trunk. Objective and Hypothesis: The primary goal of this study is to investigate how the brain responds to stimulation from these perceptive surfaces in patients with CLBP compared to healthy individuals. The investigators hypothesize that using these surfaces will lead to immediate changes in functional brain connectivity, particularly in areas responsible for body awareness and pain processing (somatosensory and salience networks). Study Procedures: The study will involve 20 patients with chronic non-specific low back pain and 20 healthy volunteers. All participants will undergo a Functional Magnetic Resonance Imaging (fMRI) session. During the scan, participants will be placed on a specialized perceptive surface. Brain activity and connectivity will be measured at rest and during specific tactile stimulation. Additionally, advanced imaging techniques (SANDI model) will be used to look at the microscopic structure of brain cells (neurons). Clinical Impact: By comparing the two groups, the study aims to identify specific "brain signatures" of recovery. This could help clinical professionals understand if perceptive surfaces can effectively restore cortical maps, leading to better personalized rehabilitation strategies for chronic pain.
Trial Details
NCT Number NCT07568353
Lead Sponsor G. d'Annunzio University
Conditions
(from sponsor)
Low Back Pain, Healthy
Related terms Low Back Pain
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov