BCI Study Published in Stroke: Vascular and Interventional Neurology Confirms IpsiHand® Improves Motor Function After Stroke

First randomized controlled trial of an at-home, noninvasive BCI therapy for chronic stroke shows more than half of patients achieved clinically meaningful recovery

VAN NUYS, Calif., Aug. 18, 2026 /PRNewswire/ -- Kandu, Inc., a commercial-stage healthcare technology company developing brain-computer interface (BCI)-enabled solutions for post-stroke recovery, has announced the publication of BCI-REHAB, the NIH-sponsored, first randomized controlled trial of an at-home, noninvasive BCI therapy for chronic stroke. The study appears 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, "At-Home BCI Rehabilitation Therapy for Chronic Upper Extremity Deficit After Stroke (BCI-REHAB): A Randomized Trial," was published online ahead of print on August 13 and will be included in the October print issue of the journal.

The findings establish that patients using the U.S. Food and Drug Administration (FDA)-cleared IpsiHand^® System achieved significantly greater improvement in upper extremity motor function than those following a standard home exercise program. The study results were first presented as an oral abstract at the International Stroke Conference (ISC) in February 2026, and the peer-reviewed journal publication shows the gravitas of this key data.

"This is the first randomized trial to show that engaging preserved ipsilateral neural signals through a noninvasive brain-computer interface can drive clinically meaningful motor recovery in chronic stroke," said Eric C. Leuthardt, MD, Chief Scientific Officer of Kandu and principal investigator of the study. "With this additional evidence, patients and their families, who were told years ago that chronic stroke recovery was unlikely, now have further evidence that says otherwise."

The trial compared at-home BCI-enabled therapy using IpsiHand with a conventional at-home exercise program. Participants were at least six months post-stroke with persistent upper extremity weakness and were directed to complete their assigned therapy one hour per day, five times per week over 12 weeks, with no in-clinic appointments in the ensuing period. The enrolled participants represented a broad population spanning severe, moderate and mild deficits, ages 19–82 years old, and 0.5 to 30.1 years since stroke onset. The trial was stopped early for efficacy, and 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 6.0 point overall gain in the BCI group of the UE-FM score, exceeding the established Minimal Clinically Important Difference (MCID) of 5.25 for chronic stroke survivors.
• A 4.5-point greater improvement (95% CI, 1.9–7.1; p = 0.0007) in upper extremity function, as measured by the Upper-Extremity Fugl-Meyer (UEFM) scale compared to the control arm.
• A number needed to treat of just 2.2 in order for 1 patient to make clinically meaningful gains, with 55.5% of IpsiHand patients achieving MCID in 12 weeks compared to 9.6% in the control arm, an absolute difference in response of 45.8% (95% CI, 20.9–70.8; p = 0.0003).
• No serious or device-related adverse events.

Stroke often disrupts the motor pathways on the side of the brain opposite the affected hand; however, motor-intent signals from the unaffected hemisphere may persist. IpsiHand pairs a noninvasive EEG headset with a wearable handpiece that assists the motion to open and close the hand. When the system detects the patient's intention to move the impaired hand, the handpiece opens and closes it in near real time, reinforcing the neural pathways that drive recovery.

"Publication in this prestigious journal is exactly the kind of evidence that changes how a therapy is viewed and adopted," said Leo Petrossian, PhD, Chief Executive Officer of Kandu, Inc. "This most recent published clinical study adds to the already large body of evidence supporting the therapeutic benefit of IpsiHand as we build a new standard of care in non-invasive chronic stroke recovery."

The authors note that because the trial measured outcomes over 12 weeks, it may not capture the full potential of longer-term use; recently published real-world evidence suggests continued improvement beyond that window. IpsiHand received FDA clearance in 2021 as a Breakthrough-Designated, de novo device for stroke rehabilitation.

The study, "At-Home BCI Rehabilitation Therapy for Chronic Upper Extremity Deficit After Stroke (BCI-REHAB): A Randomized Trial," is available open access in Stroke: Vascular and Interventional Neurology (DOI: 10.1161/SVIN.126.002345). The trial was funded by the National Institutes of Health and Neurolutions, Inc., a wholly-owned subsidiary of Kandu, Inc.

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 hemiparesis and/or hemiplegia 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:
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SOURCE Kandu, Inc.