Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients
Spinal Cord Injury Cervical
About this trial
This is an interventional treatment trial for Spinal Cord Injury Cervical focused on measuring Neuromodulation, Transcranial Direct Current Stimulation, tDCS, Upper limb, Functional recovery, Early rehabilitation, Incomplete tetraplegia
Eligibility Criteria
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 in progress.
Sites / Locations
- Montecatone Rehabilitation Institute S.p.A.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active tDCS (A)
Sham tDCS (S)
Two daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs. Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too.
Two daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs. Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too.