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 range

18 Years – 74 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Spinal Cord Injury Cervical trials