Randomized Controlled Trial Demonstrated Positive Outcomes for FDA-Cleared Brain-Computer Interface IpsiHand® System in Chronic Stroke Rehabilitation

Post-market randomized study showed clinically meaningful improvement in upper extremity motor function compared to usual care

VAN NUYS, Calif., Feb. 12, 2026 /PRNewswire/ -- Kandu, Inc., a healthcare technology company developing brain-computer interface (BCI)–enabled solutions for post-stroke recovery, today announced results from the first randomized controlled trial evaluating an FDA-cleared, non-invasive BCI therapy in chronic stroke survivors. The findings, presented at the International Stroke Conference (ISC) 2026 on February 6 in New Orleans, showed that patients using the IpsiHand System achieved significantly greater improvements in upper extremity motor function than those participating in a home exercise program, with a number needed to treat (NNT) of 2.2 for one patient to achieve a clinically meaningful functional benefit.

The results were presented by Eric C. Leuthardt, MD, MBA, during an oral abstract in the main event at ISC 2026. The abstract, "A randomized trial of an at-home brain-computer interface therapy compared to standard exercise therapy for chronic upper extremity motor deficit after stroke," detailed outcomes from a post-market randomized controlled study evaluating the clinical performance of IpsiHand®. The device received U.S. Food and Drug Administration clearance in 2021 as a Breakthrough-Designated, de novo 510(k) device for stroke rehabilitation.

The study compared at-home BCI-enabled therapy using IpsiHand with a conventional at-home exercise program. Patients were directed to  complete their assigned therapy five times per week over a 12-week period. Participants were at least six months post-stroke with persistent upper extremity hemiparesis or hemiplegia, with no upper or lower limits on baseline Upper Extremity Fugl-Meyer (UEFM) scores. The study enrollment was stopped early for efficacy following a planned interim analysis. A total of 62 participants, with a mean time since stroke of 5.4 years, were included in the primary analysis (37 BCI therapy; 25 control).

Patients treated with BCI therapy showed a mean improvement of 6.0 points on the UEFM scale, compared to an improvement of 1.5 points in the control group, representing a 4.5-point treatment advantage (95% CI 1.9–7.1; p = 0.0007). Importantly, the average improvement in the BCI group exceeded the Minimal Clinically Important Difference (MCID) of 5.25, indicating functional gains considered meaningful to patients. More than half of patients receiving BCI therapy (55.5%) achieved a clinically meaningful response, compared to 9.6% of patients in the control group—an absolute difference of 45.8 percentage points (95% CI 10.9–70.8; p = 0.0003).

Stroke often disrupts contralateral motor pathways; however, ipsilateral motor intent signals from the unaffected hemisphere may persist. "This randomized trial shows that engaging preserved ipsilateral neural signals through a noninvasive brain-computer interface can drive meaningful motor recovery in chronic stroke," said Dr. Leuthardt, Chief Scientific Officer and principal investigator of the study.

"This data fundamentally challenges the long-standing belief that recovery after stroke permanently plateaus after the first few months," said Leo Petrossian, CEO of Kandu, Inc. "For decades, patients living with chronic stroke have been told that what they regain early on is all they can expect. This randomized trial shows that with the right technology—delivered at home, without the burden of frequent clinic visits—meaningful recovery is still possible years after stroke."

He added, "IpsiHand is commercially available as prescribed durable medical equipment and used independently by patients multiple times a week in their own homes. That matters. It removes barriers to access, reduces dependence on in-clinic therapy, and allows recovery to fit into patients' lives instead of the other way around. While this study evaluated outcomes over the first 12 weeks of therapy, recently published real-world evidence demonstrates that continued use may support ongoing improvement over longer periods (Prasad NK, Goldring AL, Perry NJ, Fleisher LA, Petrossian L, Souders L, Wilk SJ. A Retrospective Analysis of Post-Stroke Rehabilitation with Real World Use of Brain-Computer Interface). Taken together, these findings support a new, more durable approach to chronic stroke recovery—one that physicians can prescribe today."

About Kandu, Inc.

Kandu, Inc. is pioneering an integrated approach to stroke recovery, combining FDA-cleared brain-computer interface technology with personalized care delivery models. The company's IpsiHand® device enables stroke survivors with upper-extremity paralysis to regain functional movement by leveraging neural intent and neuroplasticity. Kandu's solutions are designed to extend recovery beyond the hospital, supporting improved mobility, independence, and quality of life while creating durable value for patients, providers, and investors. For more information, visit kandu.com.

Media Contact:
Josie Zohny for Kandu, Inc.
[email protected]

SOURCE Kandu, Inc.