Status:
RECRUITING
Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients
Lead Sponsor:
Montecatone Rehabilitation Institute S.p.A.
Conditions:
Spinal Cord Injury Cervical
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief 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 impa...
Detailed 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 impa...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05390853
Start Date
May 24 2023
End Date
November 1 2025
Last Update
October 22 2024
Active Locations (1)
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1
Montecatone Rehabilitation Institute S.p.A.
Imola, BO, Italy, 40026