Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbano Luigi

About this trial

Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with non-traumatic spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete/complete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.

Eligibility criteria

Qualifiers

Diagnosis of NTSCI at least one year before presentation;

Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment;

Age ≥ 18 years;

Indication to spinal cord stimulation surgery for chronic pain;

Disqualifiers

Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated;

Pregnancy or breastfeeding;

Any significant psychiatric disease;

Use of illicit drugs;

Trial design

Treatments tested in this trial

  • Spinal cord stimulation surgery (device implant) and motor rehabilitation

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Albano Luigi

Lead sponsor

IRCCS San Raffaele

Sponsor institution

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator