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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: clinical-team@paradromics.com
• Phone: (512) 559 4120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.