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

NCT06620536 | Not Yet Recruiting

• 1 other identifier: REGRASP
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetraplegics

Keywords

electrodes; intraneural stimulation; hand; tetraplegia

Outcome Measures

Primary Outcomes (4)

• efficacy of REGRASP device, regarding muscle selectivity

  The muscle selectivity index will be obtained by intraneural stimulation with a TIME-4H astimulator. Single stimulation pulses (1 Hz) will be applied from each active site of each implanted TIME-4H electrode. Simultaneously, electromyographic (EMG) signals of the flexor and extensor muscles of the forearm and hand, innervated by the median and radial nerves, respectively, will be recorded. For the EMG acquisitions we will use the CE-marked Sessantaquattro+ system. The peak-to-peak value of the compound muscle action potential (CMAP), evoked by each stimulation pulse, will be calculated and normalised with respect to the maximum value obtained for each muscle during the overall experimental session. These normalised levels of muscle activation will be used to define the relationship between current intensity and muscle recruitment for each active site and so to calculate an index of muscle selectivity.

  from baseline to follow-up at month 6

• efficacy of REGRASP device, regarding muscle functional selectivity

  To assess functional selectivity, bursts of stimulation, with a duration of 0.5-1 sec, will be applied from each active site of each implanted TIME-4H. Evoked movements will be assessed using the Medical Research Council (MRC) scale. In addition, we will characterise evoked movements in terms of muscle activity patterns by recording the EMG activity of the muscles with the Sessantaquattro+ system, and in terms of kinematic patterns (amplitude and velocity) and generated force. The same experiments will then be performed by modulating the frequency of the stimulation bursts (in the range 10-100 Hz) while keeping the amplitude fixed at a value capable of generating functional movements. Thus, we will evaluate the possibility of gradually controlling the amplitude and force of the movement by adjusting the different stimulation parameters.

  from baseline to follow-up at month 6

• Muscle fatigue

  To measure muscle fatigue, experiments will be conducted in which stimulation trains will be applied for approximately 20-30 seconds. At the same time, the EMG activity of the forearm and hand muscles and the grip force generated will be recorded. Some indices of muscle fatigue found in the literature will then be calculated, which measure, for example, the rate at which muscle strength decreases over time. The values obtained will be compared with those measured during voluntary contractions and with those induced by other stimulation modalities, such as FES with surface electrodes.

  from baseline to follow-up at month 6

• Functional recovery analysis

  Restoration of hand function, in particular grasping movements and manipulation of objects, when the patient is assisted by the neuroprosthetic system. This will be assessed using four different tests with related score: * the Grasp and Release test, awarded on the basis of the number of objects the patient is able to manipulate and the number of repetitions they are able to perform in a specific time interval; * ADL test, used to evaluate the performance of the neuroprosthetic system when used during activities of daily living; * GRASSP, a measure of clinical impairment that incorporates three vital domains of upper limb function: sensation, strength and grip; * SCIM, a disability scale developed to specifically assess the ability of spinal cord injury patients to perform basic activities of daily living independently.

  from baseline to follow-up at month 6

Secondary Outcomes (1)

• to evaluate possible plastic changes in the central nervous system induced by the use of the neuroprosthetic system.

  from baseline to follow-up at month 6

Study Arms (1)

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

EXPERIMENTAL

Device: Electrical stimulation

Interventions

Electrical stimulation DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Systemic infections.
• Central and/or peripheral nervous system comorbidity.
• Reduced joint flexibility.
• Severe spasticity of the upper limb (mAS 3).
• Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).
• Muscles not electrically excitable.
• Presence of hyperalgesia or allodynia.
• Wearers of life support devices that could be adversely affected by electromagnetic interference, such as pacemakers, implanted cardioverter defibrillators, etc.
• Cognitive impairment.
• Active or history of psychiatric illnesses including major depression, bipolar disorder and personality disorders (borderline or antisocial personality disorder).
• Pregnancy.
• History of alcohol or substance abuse.
• Acquired brain injury with residual deficits.
• Participation in other clinical trials.
• Known allergies/hypersensitivity to TIME-4H electrode materials.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, Italy, 50134, Italy

Location

MeSH Terms

Conditions

Quadriplegia

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Central Study Contacts

Sandra Pfanner, MD

CONTACT

0557948377; pfanners@aou-careggi.toscana.it

Salvatore De Masi, MD

CONTACT

0557947807; demasis@aou-careggi.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

IT (1)