Status:
COMPLETED
Neural Stimulation for Hand Grasp
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de Recherche en Informatique et en Automatique
NEURINNOV
Conditions:
Quadriplegia
Eligibility:
All Genders
18-65 years
Phase:
NA
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, ...
Detailed Description
Electrical stimulation of the muscles has been used for decades in rehabilitation units specializing in the treatment of spinal cord injuries. It has been shown to be effective in building muscle and ...
Eligibility Criteria
Inclusion
- Informed consent signed
- Patient affiliated to a social security (state medical aid excepted).
- Neurological level ≥ C7
- 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)
- 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
Exclusion
- 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.).
- infectious pathology under treatment at the inclusion visit
- 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
- electrical mapping identified as negative during the inclusion visit, i.e. with muscles revealing a rating \< 4 MRC for at least one of the extensors (ECRL, ECRB, EDC, EPL) or one of the flexors (FPL, FDS, FDP).
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04306328
Start Date
October 15 2020
End Date
December 11 2020
Last Update
February 25 2021
Active Locations (1)
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1
Service MPR: USSAP Centre Bouffard-Vercelli, Pôle Santé du
Perpignan, France, 66962