Recruiting

Connexus BCI

Sponsor:

Paradromics

Code:

NCT07357428

Conditions

Amyotrophic Lateral Sclerosis

Neuromuscular Disease

Stroke

Tetraplegia/Tetraparesis

Cervical Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Connexus Brain-Computer Interface

Study Details

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Neuromuscular Disease

Stroke

Tetraplegia/Tetraparesis

Cervical Spinal Cord Injury

Study ID

NCT07357428

Start date

Mar 31, 2026

Status verified date

Apr, 2026

Completion date

Jan, 2032

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Connect-One

Interventions

Connexus Brain-Computer Interface

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

Primary outcome measure

  • Primary Safety: Number of Subjects With Device Related Adverse Events [ Time Frame: Up to 12 months post-implant ]

Central Contacts and Locations

Central contacts

Paradromics Clinical Team

(512) 559 4120clinical-team@paradromics.com

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

Paradromics

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • BCI
  • ALS
  • Paradromics
  • speech
  • dysarthria
  • neural injury
  • progressive neuromuscular disease
  • stroke
  • assistive technology
  • communication device
  • brain computer interface

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paradromics on 2026-04-14.