Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients

Trial details

Who runs it

Montecatone Rehabilitation Institute S.p.A.

Trial code

NCT05390853

Record updated

8 May 2026

Original description

Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.Read full original descriptionShow less

Pilot Randomized Controlled Study on Neuromodulation Through Active tDCS Versus Sham tDCS to Support Upper Limb Motor and Functional Recovery in Sub-acute, Incomplete, Tetraplegic Spinal Cord Injured Patients

Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.

Inclusion: Traumatic SCI; SCI neurological level, according to the American Spinal Injury Association (ASIA) definitions, from C3 to C7, included; incomplete SCI (i.e. ASIA Impairment Scale: B, C or D); distance from the SCI event: from 3 to 6 months; residual motor ability of the target upper limb; stable clinical conditions; tolerance to sitting position for at least 45 minutes; subjects capable and collaborating, able to give informed consent in person.

Exclusion: presence of cerebral metallic implants (clips) or intracranial implants (e.g. ventriculoperitoneal shunt); history of epilepsy or previous state of epileptic disease; concomitant pre-existing clinical conditions that may interfere with movements of the target arm or hand (e.g. severe osteoarthritis, joint injuries, plexus injuries, peripheral nerve injuries, partial amputations); positive history of brain lesions; history of psychotic disorders; history of severe neurodegenerative disease; history of drugs abuse; use of antiepileptic drugs blocking Sodium o Calcium channels (e.g. Carbamazepine) or N-Methyl-D-Aspartate receptor antagonists (e.g. Dextromethorphan); presence of implanted devices (e.g. pacemakers, intrathecal infusers, neurostimulators, hearing aids); mechanical ventilation in place; further contraindications to the use of TMS for PEMs elicitation (e.g. migraine with aura, permanent head / face tattoos); presence of brain tumor; pregnancy in progress.

ClinicalTrials.gov NCT05390853