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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorG. d'Annunzio University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 18 and 45 years

Right-handed dominance

Good general health condition

Ability to provide written informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perceptive Surface (SU-PER mat)

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CLBP PatientsExperimental treatment 1 intervention
Group B: Healthy ControlsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional Connectivity Changes in Somatosensory and Salience Networks

Time frame
Periprocedural

Secondary outcomes

1

Neuronal Microstructure Mapping (SANDI model)

Time frame
Periprocedural
2

Acute Pain Perception (Visual Analogue Scale)

Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome

Time frame
Day 1
3

Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)

Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome

Time frame
Day 1

Other outcomes

1

Brainstem Connectivity (PAG)

Time frame
Periprocedural

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: