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NOT YET RECRUITING
NCT07568353
NA

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

Sponsor: G. d'Annunzio University

View on ClinicalTrials.gov

Summary

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.

Official title: Lombalgia Cronica Aspecifica e Superfici Percettive: Rappresentazione Corticale Del Tronco Nella Risposta al Trattamento Riabilitativo - Studio Quasi-sperimentale Non Randomizzato

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-01

Completion Date

2027-03-01

Last Updated

2026-08-04

Healthy Volunteers

Yes

Interventions

DEVICE

Perceptive Surface (SU-PER mat)

The intervention consists of a postural mat equipped with sensory cones of varying elastic memory and elasticity. This tool is used as a neurocognitive rehabilitation device designed to restore body perception and postural control. The device is passive, non-magnetic, and made of MRI-compatible latex (inert material). During the fMRI session, the surface is positioned so that the participant, while lying in the scanner, perceives specific plantar or trunk tactile and proprioceptive stimuli.

Locations (1)

ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio"

Chieti, Chieti (CH), Italy