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Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.

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ClinicalTrials.gov Identifier: NCT03721861
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborators:
Institut National de la recherche en Informatique et Automatique
University Hospital, Montpellier
Mxm-Obelia
Information provided by (Responsible Party):
Clinique Beau Soleil

Brief Summary:
Functional electrical stimulation (FES) has been used for decades in rehabilitation centers. Having demonstrated efficacy for prevention of muscle atrophy following spinal cord injury (SCI), FES can also be considered for functional restoration of hand movements in the patients with complete tetraplegia belonging to group 0 or 1 of the classification of Giens. However, the majority of the systems using the FES directly stimulates the muscles (surface electrodes, intramuscular or epimysial), which increases the number of components and requires more electrical energy for the muscle activation. Nerve stimulation would activate more muscles through a reduced number of electrodes, limiting the number of internal components, reduces the risk of spreading infections and require less electrical energy for its operation.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Intra-operative neural cuff stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.
Actual Study Start Date : February 9, 2016
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Intra-operative neural cuff stimulation
    A feasibility study consists of placing 2 electrodes around the radial or medial nerves intraoperatively. The movements caused by the electrical stimulation of these nerves are observed.


Primary Outcome Measures :
  1. Selectivity of stimulation [ Time Frame: a week ]

    Electrical stimulation of the median or radial nerve via multipolar "cuff" electrodes induces electromyographic signals on a number of muscles.

    If at least 92% of cases, it is possible to selectively stimulate 4 muscle groups (the elbow extensor: triceps, the extensors of the fingers and carp: ECRL, ECRB, EDP, EPL, the flexor of the thumb: FPL and flexors of 4 fingers (II to V): FDS and FDP) to restore 4 functions (elbow, wrist and finger extensions; the 4 fingers and the thumb flexions).

    An activation of a muscle group is considered selective if both the selectivity index is ≥ 0.7 and the recruitment is ≥20%. Finally, there will be success the selective activation induces the right movements (extension of the elbow, extension of the wrist and fingers, flexion of the 4 fingers and flexion of the thumb). There will be failure otherwise.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Neurological level ≥ C7
  2. 18 years old min and max 65 years old,
  3. Complete traumatic injury: defined by A or B score on the AIS scale.
  4. patient belonging to group 0 or 1 of the Giens classification.
  5. neurological stability (no change in muscle testing)> 6 months,
  6. post-injury duration> 6 months
  7. Patients undergoing surgery to restore elbow extension.
  8. threshold of stimulation and diffusion of the studied muscles below 50 mA of intensity for a pulse width of 300 μs and a frequency of 25 Hz.
  9. positive electrical mapping of muscles with a minimum score of 4 MRC for at least one of the extensors (triceps, ECRL, ECRB, EDC, EPL) and / or flexor (FPL, FDS, FDP).

Exclusion Criteria:

  • 1. strong spasticity and contractures in flexion or extension of the upper limbs.

    2. Unstable epilepsy. 3. Unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure etc.).

    4. wearing a pacemaker. 5. Dermatological problems contraindicate the application of surface electrodes.

    6. body weight> 100kg


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721861


Contacts
Contact: Jacques TEISSIER, MD 33467759808 j.teissier@languedoc-mutualite.fr
Contact: Christine AZEVEDO, PHD 33467418692 christine.azevedo@inria.fr

Locations
France
Clinique Beau Soleil Recruiting
Montpellier, France, 34070
Contact: Jacques TEISSIER, MD    33467759808    j.teissier@languedoc-mutualite.fr   
Contact: Anthony Gelis, MD    33467046704    a.gelis@propara.fr   
Sponsors and Collaborators
Clinique Beau Soleil
Institut National de la recherche en Informatique et Automatique
University Hospital, Montpellier
Mxm-Obelia

Responsible Party: Clinique Beau Soleil
ClinicalTrials.gov Identifier: NCT03721861     History of Changes
Other Study ID Numbers: 2014A0175245
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinique Beau Soleil:
neural stimulation
quadriplegia
grasping

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms