NCT06620536

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study involves implanting intraneural electrodes in the nerve used to open and close the hand. Electrical stimulation will activate the forearm and hand muscles, and thus evoke movements such as opening and closing the fingers of the hand and wrist movements. Electrodes will be implanted temporarily and reversibly within the fascicles so that a more selective and therefore more effective stimulation can be determined. The electrodes will remain implanted for about 6 months. During this period, the results of the external electrical stimulation will be analysed through experimental sessions that will take place at the Careggi University Hospital. At the end of the study, the electrodes will be removed by surgery under general anaesthesia.

Conditions

• Tetraplegics

Interventions

Type	Name	Description
DEVICE	Electrical stimulation	Electrical stimulation of peripheral nerves for the recovery of hand function in tetraplegic patients of fundamental importance in improving quality of life.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-01
• Completion: 2026-12-01
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: Italy