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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03721861
• Other study ID #: 2014A0175245
• Status: Terminated
• Phase: N/A
• Start date: February 9, 2016
• Est. completion date: June 15, 2019

Study information

• Verified date: February 2021
• Source: Clinique Beau Soleil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 15, 2019
• Est. primary completion date: February 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Beau Soleil	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
Clinique Beau Soleil	Institut National de la recherche en Informatique et Automatique, Mxm-Obelia, University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	a week