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NOT YET RECRUITING

NCT07893470

Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury

Sponsor: Ernesto Losavio

View on ClinicalTrials.gov

Summary

This pilot controlled study aims to evaluate the clinical and instrumental effects and feasibility of transcutaneous cervical spinal cord stimulation (tSCS) combined with conventional rehabilitation in adults with spinal cord injury (SCI). A total of 20 participants will be enrolled and assigned to two parallel groups. The experimental group will receive conventional rehabilitation combined with transcutaneous cervical spinal cord stimulation using the ExaStim® system, while the control group will receive conventional rehabilitation alone. In the experimental group, stimulation will be delivered twice weekly for 4 weeks, for a total of 8 sessions. The study will primarily explore the immediate effects of a single stimulation session on motor control and muscle tone. It will also assess changes in motor function, muscle tone, and clinical, robotic, and electrophysiological measures over the 4-week intervention period, as well as feasibility, tolerability, and adverse events. Comparisons between the experimental and control groups will be exploratory, consistent with the pilot nature of the study.

Official title: Transcutaneous Spinal Cord Stimulation in Neurorehabilitation for Spinal Cord Injury: A Controlled Pilot Study of Clinical and Instrumental Outcomes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11

Completion Date

2027-11

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Spinal Cord Injury

Interventions

DEVICE

ExaStim® Transcutaneous Spinal Cord Stimulation

Transcutaneous cervical spinal cord stimulation (tSCS) will be delivered using the ExaStim® system through surface electrodes applied at the cervical level. Stimulation parameters, including electrode configuration, intensity, pulse duration, and frequency, will be individualized according to the participant's clinical response and tolerability. Stimulation will be administered in combination with conventional rehabilitation twice weekly for 4 weeks, for a total of 8 sessions, with each session lasting approximately 30-60 minutes.

OTHER

Conventional Rehabilitation

Participants will receive the conventional rehabilitation program provided as part of their standard clinical rehabilitation pathway. In the experimental arm, conventional rehabilitation will be combined with transcutaneous cervical spinal cord stimulation, whereas participants in the control arm will receive conventional rehabilitation alone.

Inclusion Criteria: * Age ≥18 years. * Diagnosis of non-progressive spinal cord injury. * American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C. * Motor function impairment resulting from spinal cord injury and consistent with the rehabilitation objectives of the study. * Clinically stable condition compatible with participation in the rehabilitation program defined by the study protocol. * Intact skin in the areas where stimulation electrodes will be applied. * Ability to tolerate transcutaneous stimulation during the preliminary stimulation parameter setting/titration phase. * No botulinum toxin treatment within the 6 months prior to enrollment. * Ability to understand and follow study procedures, directly or, where appropriate, with caregiver support. * Written informed consent provided by the participant or, where applicable, by a legally authorized representative. Exclusion Criteria: * Unstable or progressive spinal cord injury. * Acute medical conditions under active treatment that contraindicate standard rehabilitation. * Uncontrolled or inadequately managed autonomic dysreflexia. * Clinically significant and inadequately controlled orthostatic hypotension. * Uncontrolled epilepsy or seizures. * Uncontrolled cardiopulmonary disease or inadequately controlled cardiac arrhythmias. * Unhealed bone fractures or other painful musculoskeletal conditions incompatible with the planned rehabilitation treatment. * Damaged, infected, inflamed, or otherwise unsuitable skin in the areas where stimulation electrodes will be applied. * Known allergy to device or electrode materials, including hydrogel, silicone, or latex. * Presence of implanted electronic devices, including pacemakers, defibrillators, neurostimulators, or other implantable electronic devices. * Presence of internal metallic objects of unknown origin or without adequate documentation. * Pregnancy. * Morbid obesity. * Dependence on mechanical ventilation. * Uncontrolled or unstable psychiatric disorders, untreated depression, or active substance abuse when these conditions may interfere with safe and appropriate participation in study procedures. * Any other clinical condition that, in the investigator's judgment, makes participation in the study unsafe or inappropriate.

Locations (1)

ICS Maugeri S.p.A. SB IRCCS Bari

Bari, Bari, Italy