NCT04496609

Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries

Assessment of the Efficacy and Safety of Epidural Electrical Stimulation of the Lumbosacral Spinal Cord in the Symptomatic Treatment of Motor, Vesico-sphincter and Genito-sexual Disorders in Patients With Incomplete Spinal Cord Injuries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Neurological disability caused by traumatic lesions of the spinal cord is a significant challenge for medicine and society. These lesions, leading to sublesional central nervous system dysfunction, include sensorimotor, vesico-sphincter and genito-sexual disorders. To date, there is no treatment that enables spinal cord function to be restored. Preclinical studies have been able to demonstrate the recovery of locomotor activity with a combination of locomotor training, pharmacological intervention and epidural electrical stimulation of the lumbosacral spinal cord (EESS) in adult rats with spinal cord transection. An American team have recently been able to show that EESS, combined with locomotor training, caused neurological improvement in four paraplegic patients, with electromyographic muscular activation patterns similar to those observed during walking. In fact, these authors also showed an improvement, under stimulation, of the VS and GS functions, but with no detailed documentation. Starting with a conceptual and preclinical rationale, and with proof of clinical concept demonstrated in several reported cases, we propose a clinical trial with an original cross-over design to validate the hypothesis that EESS combined with training in patients with incomplete spinal cord injuries would, with a good tolerance profile, allow motor, vesico-sphincter (VS) and genito-sexual (GS) disorders to be restored in patients with incomplete spinal cord injuries.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Stimulation and automated rehabilitation / automated rehabilitation	Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
DEVICE	Automated rehabilitation / Stimulation and automated rehabilitation	Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2020-08-03
• Last updated: 2022-08-03

Locations

2 sites across 1 country: France