VAN NUYS, Calif., August 18, 2026
Kandu, Inc. announced the publication of results from BCI-REHAB, the first randomized controlled trial evaluating an at-home, noninvasive brain-computer interface (BCI) therapy for people living with chronic stroke and persistent upper-extremity weakness. Published in Stroke: Vascular and Interventional Neurology, the NIH-sponsored study found that patients using the FDA-cleared IpsiHand® System achieved significantly greater improvements in upper-extremity motor function than participants following a conventional home exercise program. The findings add important clinical evidence for BCI-enabled stroke rehabilitation and demonstrate the potential of at-home neurotechnology to support motor recovery years after a stroke.
Randomized Trial Demonstrates Clinically Meaningful Recovery
The BCI-REHAB trial compared at-home therapy using IpsiHand with a standard home exercise program. Participants were at least six months after stroke and had persistent upper-extremity impairment. They completed their assigned therapy for one hour per day, five days per week for 12 weeks, without requiring in-clinic appointments during the intervention period. The primary analysis included 62 participants, comprising 37 patients in the BCI therapy group and 25 in the control group. Participants represented a broad range of ages, stroke severity and time since stroke, with the average time since stroke reaching 5.4 years. The trial was stopped early because of efficacy. Patients receiving IpsiHand demonstrated a 6.0-point overall improvement in the Upper-Extremity Fugl-Meyer (UEFM) score, exceeding the established minimal clinically important difference of 5.25 points for chronic stroke survivors. Compared with the control group, the BCI group achieved a 4.5-point greater improvement in upper-extremity motor function, with a statistically significant result.
IpsiHand Combines EEG With Robotic Hand Assistance
The IpsiHand System combines a noninvasive EEG headset with a wearable handpiece designed to assist hand opening and closing. The system detects neural signals associated with the patient’s intention to move the impaired hand and uses those signals to activate the handpiece in near real time. By linking motor intent with assisted physical movement, the technology is designed to reinforce neural pathways involved in motor recovery and support neuroplasticity. The study found that 55.5% of patients using IpsiHand achieved a clinically meaningful improvement, compared with 9.6% of participants in the conventional exercise group. This represented an absolute difference of 45.8 percentage points, while the reported number needed to treat was approximately 2.2 patients for one additional patient to achieve a clinically meaningful gain. Importantly, the study reported no serious or device-related adverse events, supporting the safety profile observed during the 12-week intervention.
Advertisement
Peer-Reviewed Evidence Strengthens At-Home Stroke Care
The publication in Stroke: Vascular and Interventional Neurology provides peer-reviewed evidence supporting the use of noninvasive BCI technology for chronic stroke rehabilitation. Stroke can damage motor pathways responsible for controlling movement, but neural signals associated with movement may remain available in the unaffected hemisphere. IpsiHand is designed to detect and utilize these preserved signals to facilitate movement in the impaired hand. The technology received FDA clearance in 2021 as a Breakthrough-Designated, de novo device for stroke rehabilitation. Kandu noted that the 12-week study period may not capture the full potential of longer-term therapy, while recently published real-world evidence suggests that improvements may continue beyond the initial treatment period. The findings could contribute to the growing adoption of home-based medical technology and digital rehabilitation solutions, potentially expanding access to structured stroke recovery outside traditional clinical settings. By combining clinical evidence, FDA-cleared BCI technology and remote therapy, the study represents a significant development in MedTech and neurological rehabilitation.
Source: Kandu press relese
