Prof. Courtine’s lab at the EPFL in Lausanne tested the hypothesis in pre-clinical settings. In the next phase, the EPFL team adapted a commercially available IPG, a lead and accessories to perform the first-in-man (FIM) implants in carefully selected participants with a chronic SCI of over 12 months and up to 14 years. Since the paddle lead must be inserted in the epidural space at the lumbar level to cover the conus, hence above the spinal circuits controlling locomotion, spinal cord lesion located at T10 or above were indicated. After implantation the participants started the training and rehabilitation process under a strict medical protocol. In the STIMO study, 5 months of data were collected from each participant to analyze the short-term (a few weeks after implant) and long-term (5 months after training) results of the therapy. It is this promising data that was published in the November 1st 2018 issues of Nature and Nature Neuroscience.
Summary of the Nature publication:
- The neurostimulation system immediately enables stepping even in people with motor-complete paralyzed legs
- The Therapy enables activity-dependent plasticity to kick in, leading to neuro-recovery
- Recovery effects are present, even in the absence of stimulation
- The therapy can be used outside of the hospital for training and to support daily activities
Summary of the Nature Neuroscience publication:
- Continuous stimulation is sub-optimal for recovery of walking capabilities because it interferes with natural proprioception
- TESS preserves natural proprioception while enabling more natural and stronger stepping
In parallel, GTX Medical is currently developing the Go-2 Targeted Epidural Spinal Stimulation (TESS) system based on the findings of Prof. Grégoire Courtine’s team. Over 50 engineers and scientists in Eindhoven (NL) and Lausanne (CH) are developing the different components for a dedicated stimulation system. Like most innovative medical devices, the development and testing of such a new neuro-stimulation system is a very complex and lengthy process until it can be offered as a standard therapy for selected patients.
GTX will support future clinical studies in several European hospitals. The next study is envisioned to start in 2021. Please go to our registration section if you wish to be informed of the start of any new studies.
The newly developed complete Go-2 system from GTX Medical will undergo its final validation testing during a multi-center trial that will serve to obtain regulatory approvals, such as the CE-mark for Europe.
With positive outcomes of this study, the Go-2 system can become commercially available in more hospitals and countries. Submissions and negotiations with national health authorities and insurers will be initiated at that time to seek appropriate coverage for the therapy by health insurances.
The process of bringing a breakthrough medical technology to patients is long and complex to assure safety, efficiency and user-friendliness.
Investigational device not approved for sale in the USA