Connexus® Brain-Computer Interface to restore communication and device control

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication

This study will try the Connexus brain-computer interface to help people with severe loss of voluntary movement (for example from ALS, cervical spinal cord injury, or stroke) communicate and control computers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2 (estimated)
• Ages: 22 Years to 75 Years
• Sex: All
• Sponsor: Paradromics (industry)
• Locations: 3 sites (Sacramento, California and 2 other locations)
• Trial ID: NCT07357428 on ClinicalTrials.gov

What this trial studies

The Connect-One early feasibility study uses the Connexus brain-computer interface to decode imagined language correlates and speech and to translate neural signals into commands for computer control in people with severe loss of voluntary motor control. Participants will be enrolled at sites in Sacramento (UC Davis), Boston (Massachusetts General Hospital), and Ann Arbor (University of Michigan) and followed to collect preliminary device safety and performance data. Eligible participants are typically anarthric or have severe dysarthria, are wheelchair dependent with severely impaired upper limb function, can read and understand English, and have a study care partner and local access to a study site. Key exclusions include cognitive or psychiatric impairments that prevent compliance, other implanted devices (e.g., pacemaker, DBS), the need for regular MRIs, or other medical conditions that would interfere with participation.

Who should consider this trial

Good fit: Ideal candidates are adults with progressive neuromuscular disease or neurological injury who have anarthria or severe dysarthria, are wheelchair dependent with minimal upper-limb function, can communicate reliably in English, have a study care partner, and live within about four hours of a study site.

Not a fit: Patients who retain usable speech or hand function, who have cognitive impairment or psychiatric conditions that prevent participation, who have incompatible implanted devices, who require frequent MRIs, or who live far from a study center are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could restore or substantially improve communication and allow computer control for people with severe motor and speech impairments.

How similar studies have performed: Related intracortical and brain-computer interface programs have demonstrated proof-of-concept successes in decoding intended movements and limited speech signals, but translating those results into routine, natural speech restoration remains experimental.

Eligibility criteria

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.

Where this trial is running

Sacramento, California and 2 other locations

• University of California, Davis — Sacramento, California, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Study coordinator: Paradromics Clinical Team

Conditions: Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Stroke, Tetraplegia/Tetraparesis, Cervical Spinal Cord Injury, Dysarthria, BCI, ALS