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Clinical Trials in Italy / NCT07568353
Starting soon Not applicable

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

NCT07568353 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-08-04

Condition(s) studied

Low Back PainHealthy

Investigational drug(s) / intervention(s)

Perceptive Surface (SU-PER mat)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Aged between 18 and 45 years * Right-handed dominance * Good general health condition * Ability to provide written informed consent. For the patient group: \- Clinical diagnosis of non-specific chronic low back pain with a duration of more than 3 months For the control group: \- Healthy volunteers without a history of chronic pain Exclusion Criteria: * Contraindications to 3T Magnetic Resonance Imaging, such as pacemakers or non-compatible metallic implants * Pregnancy or breastfeeding * Presence of significant neurological or psychiatric pathologies * Current use of psychoactive medications. * Sensory or motor disorders of the lower limbs that prevent interaction with the perceptive surface. * Unstable or acute clinical conditions. * Inability to remain still during the MRI scanning procedure

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio" Chieti Chieti (CH)

More G. d'Annunzio University trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07568353 on ClinicalTrials.gov ↗ ← All trials in Italy