Neural Stimulation for Hand Grasp in People With Tetraplegia

NCT05555914 | Completed

• 1 other identifier: 2022-A00205-38
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery. Our main hypothesis is that multipolar neural electrical stimulation of the median and the ulnar nerve (flexion) and the radial nerve (extension) allows:

• on the one hand, a selective, individualized motor activation (muscle by muscle)
• on the other hand, a synergistic motor activation (association of several muscles) for the purpose of production of functional movements.

Conditions

Tetraplegia

Keywords

Tetraplegia; Neural stimulation

Outcome Measures

Primary Outcomes (1)

• Functional outcome: Number of successful trials (task completed) out of 5 trials with 5 preselected objects.

  The objective is to show that neural electrical stimulation allows the user to master the completion of each of pre-selected gripping tasks. The evaluation criteria is the number of successful trials (task completed) out of 5 trials with 5 preselected objects. For each object, a successful gripping task is a task completed in a duration \<180 sec.

  Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29

Secondary Outcomes (7)

• Functional outcome

  Following surgery from Day12: Day12, Day15, Day17, Day22, Day26 and Day29

• Strength

  Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29

• Fatigue

  Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29

• Self perception and psychological well being

  Baseline prior to surgery and following surgery: Day8, Day15, Day22, Day29

• System Usability Scale

  Following surgery : Day8 and Day29

Study Arms (1)

Neurostimulation

EXPERIMENTAL

Implantation of 3 multicontact cuff electrodes in the upper limb of patients with tetraplegia

Other: Neurostimulation

Interventions

Neurostimulation OTHER

Implantation of 3 multicontact cuff electrodes in the upper limb of patients with tetraplegia and control of the stimulation by contralateral shoulder movements

Neurostimulation

Eligibility Criteria

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

You may qualify if:

• Informed consent signed
• Patient affiliated to a social security (state medical aid excepted).
• Neurological level ≥ C7 4.18 years old ≤ age ≤ 65 years old,
• complete traumatic injury: defined by an A or B score on the AIS scale. (AIS A or - complete motor deficit under injury. This is an internationally agreed standard for describing spinal cord injury) 6.neurological stability (no change in muscle testing) \> 6 months, 7.post-injury duration \> 6 months 8.patients without active muscle resources for conventional tendon transfer surgery on the forearm and hand

You may not qualify if:

• patient deprived of liberty (by judicial or administrative decision).
• adult patient who is subject to a legal protection measure or unable to express consent
• participation in another ongoing clinical trial
• pregnant or breastfeeding women or women of childbearing age without effective contraception
• spasticity and contractures in flexion or extension of the upper limbs of a destabilizing nature.
• unstable epilepsy with a notion of a epileptic seizure that occurred within the previous 12 months.
• unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure, etc.).
• wearing a pacemaker or a spinal cord stimulator implant
• dermatological problems contraindicating the application of surface electrodes.
• body weight \>100 kg
• psychiatric condition and/or history contraindicating participation in research
• any contraindications to anesthesia and/or surgery
• hypersensitivity to low molecular weight heparin (LMWH) or to any of the excipients of the specialty used
• history of immune-mediated heparin-induced thrombocytopenia (HIT) within the last 100 days or presence of circulating antibodies
• clinically significant active bleeding or a condition associated with a high risk of bleeding

Sponsors & Collaborators

• Centre Bouffard Vercelli - USSAP: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator
• NEURINNOV: collaborator

Study Sites (1)

Rehabilitation Center Bouffard-Vercelli USSAP

Perpignan, 66000, France

Location

Related Publications (1)

• Fattal C, Teissier J, Geffrier A, Fonseca L, William L, Andreu D, Guiraud D, Azevedo-Coste C. Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration. J Neurotrauma. 2022 May;39(9-10):627-638. doi: 10.1089/neu.2021.0381. Epub 2022 Feb 2.

  PMID: 35029125 RESULT

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles FATTAL, MD, PhD

  Centre Bouffard Vercelli - USSAP

  PRINCIPAL INVESTIGATOR

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: August 29, 2022
• First Posted: September 27, 2022
• Study Start: October 10, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 29, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)