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

Paradromics · with University of Michigan, University of California, Davis · NCT07357428

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
2
US sites recruiting
3
Study start
March 31, 2026
Record last updated
April 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Connexus Brain-Computer Interface

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of California, Davis

    Sacramento, CA 95817

    Site contact: David Brandman M.D., Ph.D.

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Daniel Rubin, M.D., Ph.D.

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Matthew Willsey, M.D,. P.h.D

Study contacts (from the official record)

  • Paradromics Clinical Team · (512) 559 4120 · clinical-team@paradromics.com
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Connect-One: Early Feasibility Study of Connexus® Brain-Computer… (NCT07357428) | Bored Studies