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

Clinique Beau Soleil

Status: Terminated

Conditions: Spinal Cord Injuries

Treatments: Device: Intra-operative neural cuff stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03721861

2014A0175245

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.).

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

  4. body weight> 100kg

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)