BCIwiki (bciwiki.com) — Kandu, Inc. announced on August 18, 2026 that its IpsiHand at-home noninvasive brain-computer interface system significantly improved upper extremity motor function in an NIH-sponsored randomized controlled trial. The results were published in Stroke: Vascular and Interventional Neurology, a peer-reviewed journal published on behalf of the American Heart Association and the Society for Vascular and Interventional Neurology.
The article was published online ahead of print on August 13, 2026 and will appear in the October print issue. The trial was stopped early for efficacy, with 62 participants included in the primary analysis (37 BCI therapy; 25 control). Patients treated with BCI therapy showed a 6.0-point overall gain in the Upper-Extremity Fugl-Meyer (UEFM) score, exceeding the established Minimal Clinically Important Difference (MCID) of 5.25 for chronic stroke survivors, and a 4.5-point greater improvement (95% CI, 1.9–7.1; p = 0.0007) compared to control. A number needed to treat of 2.2 was observed, with 55.5% of IpsiHand patients achieving MCID in 12 weeks versus 9.6% in the control arm, an absolute difference of 45.8% (95% CI, 20.9–70.8; p = 0.0003). No serious or device-related adverse events were reported.
The IpsiHand system pairs a noninvasive EEG headset with a wearable handpiece that assists hand opening and closing. When the system detects the patient's intention to move the impaired hand, the handpiece opens and closes it in near real time, reinforcing neural pathways that drive recovery. IpsiHand received U.S. Food and Drug Administration (FDA) clearance in 2021 as a Breakthrough-Designated, de novo device for stroke rehabilitation. The study was funded by the National Institutes of Health and Neurolutions, Inc., a wholly-owned subsidiary of Kandu, Inc.