The TRANSFORM study is designed to follow 1,000 adults with multiple sclerosis, stroke, spinal cord injury, cerebral palsy, and other conditions over 12 months, building a dataset of quality-of-life outcomes rarely captured at this scale in these populations

SAN FRANCISCO, Sept. 9, 2026 /PRNewswire/ — Cionic, the company behind the first FDA-cleared non-invasive closed-loop neuromodulation platform for improving walking, today shared details of its TRANSFORM study, a 12-month examination of health-related quality of life in adults with upper motor neuron (UMN) conditions.

The study extends previously published pilot research, which evaluated the Cionic Neural Sleeve’s impact on quality of life in people with multiple sclerosis. Quality-of-life outcomes in UMN populations are typically assessed in controlled clinical settings and at single points in time. TRANSFORM is designed to capture them longitudinally, in participants’ own environments, and to examine how quality of life relates to symptoms that shape daily function, including spasticity, urinary incontinence, and fatigue.

“Roughly 30 million Americans live with mobility impairments caused by upper motor neuron conditions, yet their experiences are rarely counted in large-scale datasets,” said Rebecca Webster, PhD, vice president of clinical operations at Cionic. “Our intention is to build a dataset to advance the understanding of key health-related quality of life measures, so that this population can more affordably access therapies that will have the most consequential effect.”

TRANSFORM (Tracking Reported Activities and Needs for Self-care, Function, Outcomes, Relief, and Mood) follows participants across six surveys, at onboarding and at one, three, six, nine, and 12 months. Surveys are completed through the Cionic mobile application at a time and place of the participant’s choosing.

The study’s primary measure is the EQ-5D-5L, a standardized health-related quality of life instrument used widely in clinical research and health economics, covering mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Secondary measures address perceived spasticity, urinary incontinence, and fatigue.

“Our goal with this study is to build a more complete understanding of the real-world experience of those living with upper motor neuron conditions,” said Jeremiah Robison, CEO and founder of Cionic. “The early results are very encouraging. Of the 60 people who have completed their first follow-up, we are seeing an average EQ-5D improvement of 26%, with improvements across all five dimensions: from mobility and daily activities to self-care and pain. Most importantly, we are starting to understand how to optimize usage to improve these quality-of-life outcomes.”

The Cionic Neural Sleeve is an FDA-cleared Class II prescription device that delivers individualized electrical stimulation to muscles in the upper and lower leg to improve gait in people with neurological conditions. Unlike conventional functional electrical stimulation systems that target a single muscle, it uses the kinematics from the IMUs to coordinate stimulation across four muscle groups throughout the gait cycle. With both efferent and afferent stimulation, it improves walking by activating functional muscle movement and relaxing muscle spasms.

This study comes one year after the launch of the company’s second-generation Neural Sleeve, which was recognized as one of TIME’s Best Inventions of 2025. The original device made the same list in 2023.

Facts and Figures

In the four years since Cionic’s first FDA clearance, the company has transformed mobility care from concept to impact, combining scale, clinical outcomes, and customer adoption.

• 750 million steps stimulated, proving the Neural Sleeve is a key part of people’s daily lives
• 3 million hours of real-world use by Neural Sleeve users in just two years
• 94% of participants demonstrated improved gait in back-to-back paired tests
  • 68% increase to foot clearance
  • 44% improvement to ankle stability
• 30% improvement to spasticity reported by home trial participants using the Neural Sleeve 2, addressing one of the most limiting barriers to safe, independent walking
• Over 2,000 prescribers nationwide across 20+ diagnoses, showing broad clinical applicability for improving mobility
• 35 clinical, research, and advocacy partnerships, including the Shirley Ryan AbilityLab, Stanford University, the University of Washington, the National Multiple Sclerosis Society, and the Multiple Sclerosis Association of America

For more information, please visit www.cionic.com.

About Cionic

Founded in 2018 and headquartered in San Francisco, Cionic is pioneering the future of walking through its non-invasive closed-loop neuromodulation platform. With the FDA-cleared Neural Sleeve at its core, Cionic is setting a new standard for mobility care today and building toward a future where people can move further, faster, and fearlessly, across conditions. In addition to being named to the TIME Best Inventions list, Cionic was named one of Fast Company’s Most Innovative Companies of 2026.

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SOURCE Cionic