Ireland
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Recruiting Not applicable

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428 · tracked via the Priya Life Science USA tracker
Sponsor
Paradromics
Phase
Not applicable
Started
2026-03-31
Last updated
2026-04-14

Condition(s) studied

Amyotrophic Lateral SclerosisNeuromuscular DiseaseStrokeTetraplegia/TetraparesisCervical Spinal Cord InjuryDysarthria

Investigational drug(s) / intervention(s)

Connexus Brain-Computer Interface

Connexus Brain-Computer Interface: The Connexus Brain Computer Interface is an implantable brain-computer interface.

Study summary

The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI). The Connexus BCI is intended to be used as: (1) an assistive communication device to decode imagined language correlates and speech for patients with impaired communication as a result of severe loss of voluntary motor control; and (2) to provide control of computer devices for individuals with severe loss of voluntary motor control of the upper extremity.

Eligibility

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Clinical diagnosis of a progressive neuromuscular disease or a neurological injury. * Clinical diagnosis of anarthria or severe dysarthria. * Wheelchair dependent with severely impaired upper limb function. * Has a reliable method of communication and the ability to read and understand the English language. * Has a study care partner (e.g. caregiver or multiple caregivers) for the duration of the study. * Lives within a 4-hour radius of a study site. Exclusion Criteria: * Cognitive impairment or psychiatric illness that could impact the ability to comply with study requirements, as determined by the Study Investigator. * Co-morbidities or an ongoing chronic medical condition that would impair the ability to comply with study requirements. * The presence of another implanted device, like a pacemaker, deep brain stimulator, or implantable pulse generator. * Requires, or is expected to require regular MRI scans for on-going medical conditions. * In the opinion of the Study Investigator, the patient is not an appropriate candidate for the study, for reasons that could place the patient at undue risk or otherwise result in non-compliance with the study requirements.

Primary outcome measure(s)

  • Primary Safety: Number of Subjects With Device Related Adverse Events — Up to 12 months post-implant
    Device Related Adverse Events: Number of subjects with device-related adverse events

Trial sites (3)

FacilityCityRegionStatus
University of California, Davis Sacramento California Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07357428 on ClinicalTrials.gov ↗ ← All trials in the USA