A Personalized Approach to Treating Gait Issues in Multiple Sclerosis: the Cionic Neural Sleeve

Douglas A. Wajda, PhD

Multiple sclerosis (MS), a chronic, demyelinating disorder, can cause several different sensory, pyramidal, cerebellar, and visual symptoms, as well as gait dysfunction, otherwise considered a leading cause for disability in this patient population. Gait and balance dysfunction can directly affect the quality of life and activities of daily living in patients with MS, hence the importance of effective treatment strategies. To date, several of the tested approaches have been limited to 1 muscle group, ultimately restricting the amount of therapeutic potential available.

Developed by Cionic, the Neural Sleeve is an investigational functional electrical stimulation approach designed to treat in MS. At the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held May 29-June 2, in Nashville, Tennessee, a pilot study looked at the efficacy of the sleeve in a small cohort of patients, focusing on addressing foot drop and inversion/eversion. On average, participants exhibited –9.9° (±3.3°) of dorsiflexion (DF) at heel strike and 11.8° (±7.1°) of inversion during swing for the unstimulated walking condition. During the stimulated walking condition, DF values significantly increased (P < .001) by an average of 8.2° ± 3.7° and inversion was significantly reduced (P = .013) by 5.7° (±4.9°).

Additional findings showed improvements to DF at heel strike and reductions in inversion during swing in all 8 participants with FES delivered by the Neural Sleeve. Douglas A. Wajda, PhD, an assistant professor of neurology at Cleveland State University, sat down with NeurologyLive® at the meeting to discuss the sleeve and its utility in treating gait dysfunction in MS. Wadja provided commentary on the feasibility of the sleeve, the next steps in its clinical development, and some of the unmet research to further advance gait treatment going forward.

NeurologyLive: How does the Neural Sleeve operate? Discuss its function.

Douglas A. Wadja, PhD: With the Neural Sleeve, it allows for functional electrical stimulation of multiple muscle groups. Previous devices have usually only permitted stimulation of one muscle at a time. The advantage of the Neural Sleeve is that we can customize the amount of stimulation that individuals receive based on their specific gait impairment. It also uses array-based electrode placement, which allows us to tune the stimulation to specific locations on the leg, making it more functional during the initial setup and simpler for individuals to control their stimulation parameters at home. The primary advantage, compared to previous techniques, is that the Neural Sleeve is an active device that helps improve muscle strength and neurological timing, unlike standard ankle orthoses that only eliminate drop foot passively.

How feasible is this therapeutic?

From a feasibility standpoint, it is designed in a way that makes it really functional for home use. Patients can put it on and operate it themselves using a simple Velcro system and alignment guidelines. Everything the sleeve does is controlled through a phone app optimized for participant use. Once they have their sleeve on, they can open the app, and they’re presented with the modules they need. They can click a button to start walking, confirm their settings, and the device will adjust stimulation based on their walking pace. Patients can also adjust the stimulation throughout the day based on their fatigue or desired effort.

What are some of the greatest takeaways from the clinical trial?

For this study, we had eight individuals with multiple sclerosis come to our research lab at Cleveland State. These individuals had no prior experience with the Neural Sleeve. We aimed to see if we could instantaneously improve ankle kinematics, specifically if we could make their foot move in a way that is advantageous for their walking. All eight participants self-reported having foot drop and weakness. We wanted to ensure their foot raised up when getting ready to strike the ground and that it remained flat to avoid landing on the outside edge, which can cause falls. Participants walked without any stimulation first, then with the Neural Sleeve after setup and tuning. We observed significant improvements in dorsiflexion angles and reduction in foot inversion, indicating better foot positioning during walking.

What are the next steps in advancing this treatment?

We have moved on to a pilot trial analyzing the effects of home use of the Neural Sleeve. Participants use the sleeve daily and come to the lab for measurements. We aim to quantify walking improvements and activity levels. The goal is to submit for grant funding for a larger trial using this pilot data to show feasibility and effectiveness for home use.

In general, how can we continue to tackle the issues of gait dysfunction in MS?

I’ve been studying gait and MS for probably 10 years now, and a lot of it has rested on pharmaceutical or device routes. The symptoms present themselves heterogeneously in individuals. The advantage of the Neural Sleeve is its ability to stimulate multiple muscle groups and tailor the stimulation to individual needs, addressing issues like spasticity and muscle weakness. This personalized approach, combined with other regimens such as exercise and pharmaceuticals, can significantly improve gait in MS patients. The Neural Sleeve’s adaptability and ease of use make it a valuable addition to transdisciplinary treatment structures, helping patients in their daily lives.

Transcript edited for clarity.