Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients
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
Montecatone Rehabilitation Institute S.p.A.
30 participants
May 24, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria13
- 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.
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Interventions
tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Active stimulation is carried out with a current intensity of 2 milliAmpere. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.
tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Sham stimulation is carried out through a dedicated program, which increases the current for several seconds up to the target intensity and then decreases it gradually in a few seconds, so that subjects experience the same itching and tingling experience as in active stimulation, but they do not receive any significant therapeutic currents. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.
Locations(1)
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NCT05390853