Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03721861|
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
|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|
- 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.
- 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.
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
|Contact: Jacques TEISSIER, MDfirstname.lastname@example.org|
|Contact: Christine AZEVEDO, PHDemail@example.com|
|Clinique Beau Soleil||Recruiting|
|Montpellier, France, 34070|
|Contact: Jacques TEISSIER, MD 33467759808 firstname.lastname@example.org|
|Contact: Anthony Gelis, MD 33467046704 email@example.com|