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

Exclusion Criteria

• •1. Systemic infections.
• •2. Central and/or peripheral nervous system comorbidity.
• •3. Reduced joint flexibility.
• •4. Severe spasticity of the upper limb (mAS 3).
• •5. Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).
• •6. Muscles not electrically excitable.
• •7. Presence of hyperalgesia or allodynia.
• •8. Wearers of life support devices that could be adversely affected by electromagnetic interference, such as pacemakers, implanted cardioverter defibrillators, etc.
• •9. Cognitive impairment.
• •10. Active or history of psychiatric illnesses including major depression, bipolar disorder and personality disorders (borderline or antisocial personality disorder).
• •11. Pregnancy.
• •12. History of alcohol or substance abuse.
• •13. Acquired brain injury with residual deficits.
• •14. Participation in other clinical trials.
• •15. Known allergies/hypersensitivity to TIME-4H electrode materials.
• •16. Life expectancy of less than one year.
• •17. Contraindications to general anaesthesia (patient refusal, severe aortic stenosis, significant pulmonary disease, etc.).