Using tDCS to improve upper limb recovery in patients with incomplete tetraplegia
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
This study is testing if a new brain stimulation technique can help people with incomplete tetraplegia recover better use of their arms after a spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Montecatone Rehabilitation Institute S.p.A. Academic / other |
| Locations | 1 site (Imola, BO) |
| Trial ID | NCT05390853 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of Transcranial Direct Current Stimulation (tDCS) in enhancing upper limb recovery in patients with incomplete tetraplegia following spinal cord injury. Participants will receive either active tDCS or a sham treatment in conjunction with traditional physiotherapy during the sub-acute phase of their recovery. The study aims to assess the feasibility and efficacy of this non-invasive neuromodulation technique to improve motor function in the upper limbs. The research is being conducted at the Montecatone Rehabilitation Institute, focusing on patients who are 3 to 6 months post-injury.
Who should consider this trial
Good fit: Ideal candidates are individuals with traumatic spinal cord injuries at the cervical level (C3 to C7) who exhibit incomplete neurological function and have some residual motor ability.
Not a fit: Patients with complete spinal cord injuries, severe neurodegenerative diseases, or those with implanted medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance functional recovery of the upper limbs in patients with spinal cord injuries.
How similar studies have performed: While there are limited studies on tDCS for upper limb recovery in tetraplegic patients, some research has shown promise in using neuromodulation techniques for functional recovery in spinal cord injury cases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Imola, BO
- Montecatone Rehabilitation Institute S.p.A. — Imola, Bo, Italy (Recruiting)
Study contacts
- Principal investigator: Silvia Olivi, MD — Montecatone Rehabilitation Institute S.p.A.
- Study coordinator: Silvia Olivi, MD
- Email: silvia.olivi@montecatone.com
- Phone: +39 0542 632811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.