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

NCT ID: NCT06620536

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restoring hand function in patients with tetraplegia by intraneural stimulation of peripheral nerves

Group Type: EXPERIMENTAL

Electrical stimulation

Intervention Type: DEVICE

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

Interventions

Electrical stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men or women aged between 18 and 70.

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

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

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Ospedaliero Universitaria Careggi

Florence, Italy, Italy

Countries

Italy

Central Contacts

Sandra Pfanner, MD

Role: CONTACT

pfanners@aou-careggi.toscana.it

0557948377

Salvatore De Masi, MD

Role: CONTACT

demasis@aou-careggi.toscana.it

0557947807

Facility Contacts

Salvatore De Masi, MD

Role: primary

demasis@aou-careggi.toscana.it

0557947807

Other Identifiers

REGRASP

Identifier Type: -

Identifier Source: org_study_id