TerminatedNot Applicable

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

Stopped: Recruitment inefficiency, due to overly stringent selection criteria

Italy13 participantsStarted 2023-05-24

Plain-language summary

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.

Who can participate

Age range18 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * presence of implanted devices (e.g. pacemakers, intrathecal infusers, neurostimulators, hearing aids); * positive history of brain lesions; * presence of cerebral metallic implants (clips) or intracranial implants (e.g. ventriculoperitoneal shunt); * history of epilepsy or previous state of epileptic disease; * mechanical ventilation in place; * history of psychotic disorders; * history of severe neurodegenerative 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); * use of antiepileptic drugs blocking Sodium o Calcium channels (e.g. Carbamazepine) or N-Methyl-D-Aspartate receptor antagonists (e.g. Dextromethorphan); * history of drugs abuse; * further contraindications to the use of TMS for PEMs elicitation (e.g. migraine with aura, permanent head / face tattoos); * presence of brain tumor; * pregnancy…

What they're measuring

Change in motor function, after the tDCS treatment period completion

Timeframe: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1)

Trial details

NCT IDNCT05390853

SponsorMontecatone Rehabilitation Institute S.p.A.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-27