Back to resultsUse of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.
Primary Purpose
Spinal Cord Injuries
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intra-operative neural cuff stimulation
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring neural stimulation, quadriplegia, grasping
Eligibility Criteria
Inclusion Criteria:
- Neurological level ≥ C7
- 18 years old min and max 65 years old,
- Complete traumatic injury: defined by A or B score on the AIS scale.
- patient belonging to group 0 or 1 of the Giens classification.
- neurological stability (no change in muscle testing)> 6 months,
- post-injury duration> 6 months
- Patients undergoing surgery to restore elbow extension.
- 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.
- 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
Sites / Locations
- Clinique Beau Soleil
Outcomes
Primary Outcome Measures
Selectivity of stimulation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03721861
First Posted
October 19, 2018
Last Updated
February 8, 2021
Sponsor
Clinique Beau Soleil
Collaborators
Institut National de la recherche en Informatique et Automatique, University Hospital, Montpellier, Mxm-Obelia
1. Study Identification
Unique Protocol Identification Number
NCT03721861
Brief Title
Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.
Official Title
Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment is finished
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
February 9, 2016 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Beau Soleil
Collaborators
Institut National de la recherche en Informatique et Automatique, University Hospital, Montpellier, Mxm-Obelia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
neural stimulation, quadriplegia, grasping
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Intra-operative neural cuff stimulation
Intervention Description
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 Measure Information:
Title
Selectivity of stimulation
Description
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.
Time Frame
a week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neurological level ≥ C7
18 years old min and max 65 years old,
Complete traumatic injury: defined by A or B score on the AIS scale.
patient belonging to group 0 or 1 of the Giens classification.
neurological stability (no change in muscle testing)> 6 months,
post-injury duration> 6 months
Patients undergoing surgery to restore elbow extension.
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.
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
Facility Information:
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32429963
Citation
Tigra W, Dali M, William L, Fattal C, Gelis A, Divoux JL, Coulet B, Teissier J, Guiraud D, Azevedo Coste C. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia. J Neuroeng Rehabil. 2020 May 19;17(1):66. doi: 10.1186/s12984-020-00676-4.
Results Reference
derived
Learn more about this trial
Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.
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