STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).
I found an interesting study through CNN about the STIMO clinical trial that was published on Nature Medicine on February 2022.
Here’s the abstract:
Epidural electrical stimulation (EES) targeting the dorsal roots of lumbosacral segments restores walking in people with spinal cord injury (SCI). However, EES is delivered with multielectrode paddle leads that were originally designed to target the dorsal column of the spinal cord. Here, we hypothesized that an arrangement of electrodes targeting the ensemble of dorsal roots involved in leg and trunk movements would result in superior efficacy, restoring more diverse motor activities after the most severe SCI. To test this hypothesis, we established a computational framework that informed the optimal arrangement of electrodes on a new paddle lead and guided its neurosurgical positioning. We also developed software supporting the rapid configuration of activity-specific stimulation programs that reproduced the natural activation of motor neurons underlying each activity. We tested these neurotechnologies in three individuals with complete sensorimotor paralysis as part of an ongoing clinical trial (www.clinicaltrials.gov identifier NCT02936453). Within a single day, activity-specific stimulation programs enabled these three individuals to stand, walk, cycle, swim and control trunk movements. Neurorehabilitation mediated sufficient improvement to restore these activities in community settings, opening a realistic path to support everyday mobility with EES in people with SCI.
I didn’t have access to the actual publication so I was unable to look at the study in detail. Someday I will be able to afford these things. But anyway, from what I can gather from the CNN article (secondary source), three men were part of the study aged 29-41 from a hospital of the Swiss Federal Institute of Technology.
Electrodes were implanted into the epidural space (and therefore an invasive procedure) between the vertebrae and spinal cord membrane. The electrodes are similar to a pacemaker implant actually and have a lifespan of nine years. This is a pretty good battery life – I wonder if with intensive use in daily activities if this will be drastically less than the advertised nine years.
Much of what is mentioned is focused on mobility and PT – 6 minute walk test, standing endurance, parallel bars, overhead suspending supports, etc. Apparently, participants were able to demonstrate mobility ‘hours’ after the surgical intervention, with one participant even climbing stairs. They received physical therapy 4x a week, but there was no mention of any occupational therapy.
The device does need to be turned on for participants to demonstrate this new mobility and it seems to be paired with a tablet with specific programs coded for activities: standing, walking, swimming. This is some real sci-fi stuff come to life! It reminds me of The Matrix when Neo and Trinity learn Kung Fu and how to fly helicopters, respectively, from programs being uploaded to their CNS. Of course, there is more to it in this case with participants needing intensive rehabilitation and training.
“The more they train, the more they achieve, so they need the motivation to be able to stand a long time,” Bloch said of the participants’ progress.
Bowel and Bladder Function
I wonder if this technology can be used to promote bowel and bladder function in these SCI survivors. This would drastically improve participants’ quality of life as managing one’s bowel and bladder after a SCI is life-changing and requires a lot of effort – self-cathing, digital stimulation, adaptive equipment, DME, and more.
Intuitively, it seems that if the right set of nerves in the spinal column are stimulated (motor) that something similar can be achieved to promote bowel and bladder function? My guess is that this stimulation is primarily, if not only motor signals, but it would be neat to have it work for sensory function as well such as sending signals of when the bladder is full. With motor and sensory nerve signals being sent past the level of injury in both directions, it would be incredible for participants to regain more normal bowel and bladder function.
It would be cool if this tech could be used to promote sensory input – pain, temperature, light touch, proprioception. This would be life-changing for so many occupations: showering, toileting, sex, mobility, IADLs, even socialization while being intimate.
Safety, Security, Cost
As a tablet is mentioned, I wonder what role it plays and how it connects to the individual’s implant. Bluetooth? WIFI? Is it safe and secure? I have many privacy and security concerns, e.g., hacking if this were to be more mainstream. I would imagine a major barrier with this type of technology and intervention is cost. The candidate needs to be able to meet specific criteria, get the implant, get rehabilitation, and follow up with the team. These costs should hopefully go down as we learn more from the data and continued research.
I wonder what the limitations of this study are beside the small sample size and gender of the participants. The actual study probably describes the level of their SCI and what their ASIA is. What can it not do? Is there input delay? Did participants experience any adverse effects?
This is very exciting news and this technology is very cutting edge. Another article that reported on this study mentioned an application would be stem cell growth for SCI survivors used in conjunction with this type of epidural electrical stimulation.
Occupational therapy can provide a lot of benefit to being part of studies and projects as these.
- What do you think of this?
- How can OT be applied to this technology in terms of occupations?
- What outcome measures would you use? FIM/CARE? AM-PAC 6 Clicks?
- Something else?