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

NCT ID: NCT03721861

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-09
• Study Completion Date: 2019-06-15

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la recherche en Informatique et Automatique

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Mxm-Obelia

INDUSTRY

Sponsor Role: collaborator

Clinique Beau Soleil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Beau Soleil

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32429963 (View on PubMed)

Other Identifiers

2014A0175245

Identifier Type: -

Identifier Source: org_study_id