Clinical trial NCT03721861: 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
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: neural stimulation
quadriplegia
grasping
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
Collaborators: name: Institut National de la recherche en Informatique et Automatique
name: University Hospital, Montpellier
name: Mxm-Obelia
First posted: 2018-10-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Selectivity of stimulation
timeFrame: a week
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Beau Soleil
Study officials:
References:
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.