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Not yet recruiting NCT06620536

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

No phase Interventional Tetraplegics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical stimulation.
Who it may be relevant to
Registry conditions: Tetraplegics. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • efficacy of REGRASP device, regarding muscle selectivity [Time frame: from baseline to follow-up at month 6]
  • efficacy of REGRASP device, regarding muscle functional selectivity [Time frame: from baseline to follow-up at month 6]
  • Muscle fatigue [Time frame: from baseline to follow-up at month 6]
  • Functional recovery analysis [Time frame: from baseline to follow-up at month 6]
Secondary outcome measures (1)
  • to evaluate possible plastic changes in the central nervous system induced by the use of the neuroprosthetic system. [Time frame: from baseline to follow-up at month 6]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Life expectancy of less than one year.
  • Contraindications to general anaesthesia (patient refusal, severe aortic stenosis, significant pulmonary disease, etc.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Azienda Ospedaliero Universitaria Careggi — Florence

Identifiers

NCT: NCT06620536 · REGRASP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗