Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves

ConditionTetraplegics
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAzienda Ospedaliero-Universitaria Careggi

About this trial

The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.

Eligibility criteria

Qualifiers

Men or women aged between 18 and 70.

Spinal cord injury at the C5-6 level, with complete motor paralysis (ASIA A or ASIA B).

Chronic injury (> 6 months), with stable clinical condition.

Disqualifiers

Systemic infections.

Central and/or peripheral nervous system comorbidity.

Reduced joint flexibility.

Severe spasticity of the upper limb (mAS 3).

Trial design

Treatments tested in this trial

  • Electrical stimulation

Treatment groups

2 Participants
are divided into 1 treatment group

Sponsors and collaborators

Azienda Ospedaliero-Universitaria Careggi

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator