Neural Stimulation for Hand Grasp

NCT04306328 | Completed DMC

• 1 other identifier: APHP190280
• 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 and 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 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

Quadriplegia

Keywords

Percutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Selectivity index of the configurations which allow an individualized recruitment of the different muscles at D+29

  Selectivity index of the configurations (active contacts of the electrode and stimulation parameters) which allow an individualized recruitment of the different muscles at D+29 based on the combination of the increase of the Root Mean Square (RMS) value of the Electromyography (EMG) and variation of 10% of the maximum distance covered by the considered segment compared with the rest position.

  End of the protocole (day 29)

Secondary Outcomes (8)

• Motor Capacities Scale (MCS)

  Day 29

• Test n°1 of the 400 Points assessment

  Day 29

• The rate in % of total tests of grasping objects.

  Day 29

• Optimal stimulation strategies obtained for a synergistic functional control

  Day 29

• The impedance of the electrode contacts.

  Day 29

Study Arms (1)

Neurostimulation

EXPERIMENTAL

Device: Neurostimulation

Interventions

Neurostimulation DEVICE

Implantation of 2 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
• 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)
• neurological stability (no change in muscle testing) \> 6 months,
• post-injury duration \> 6 months
• 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.
• 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

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

Study Sites (1)

Service MPR: USSAP Centre Bouffard-Vercelli, Pôle Santé du

Perpignan, 66962, France

Location

Related Publications (1)

• Coste CA, William L, Fonseca L, Hiairrassary A, Andreu D, Geffrier A, Teissier J, Fattal C, Guiraud D. Activating effective functional hand movements in individuals with complete tetraplegia through neural stimulation. Sci Rep. 2022 Oct 6;12(1):16189. doi: 10.1038/s41598-022-19906-x.

  PMID: 36202865 DERIVED

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

  Assistance Publique - Hôpitaux de Paris

  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: January 31, 2020
• First Posted: March 12, 2020
• Study Start: October 15, 2020
• Primary Completion: November 24, 2020
• Study Completion: December 11, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)