Clinical trial NCT06620536: Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves
Official title: Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tetraplegics
Keywords: electrodes
intraneural stimulation
hand
tetraplegia
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna di Pisa
First posted: 2024-10-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 (\&gt; 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.).

Primary outcomes:
measure: efficacy of REGRASP device, regarding muscle selectivity
timeFrame: from baseline to follow-up at month 6
measure: efficacy of REGRASP device, regarding muscle functional selectivity
timeFrame: from baseline to follow-up at month 6
measure: Muscle fatigue
timeFrame: from baseline to follow-up at month 6
measure: Functional recovery analysis
timeFrame: from baseline to follow-up at month 6
Secondary outcomes:
measure: to evaluate possible plastic changes in the central nervous system induced by the use of the neuroprosthetic system.
timeFrame: from baseline to follow-up at month 6
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
References: