Summary

Eligibility
for people ages 22-75 (full criteria)
Location
at Ann Arbor, Michigan
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Stroke, Tetraplegia/Tetraparesis, Cervical Spinal Cord Injury, Dysarthria, BCI, ALS, Paradromics, speech, neural injury, progressive neuromuscular disease, assistive technology, communication device, brain computer interface, Neuromuscular Diseases, Quadriplegia, Connexus Brain-Computer Interface, Connect-One

Eligibility

You can join if…

Open to people ages 22-75

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of Michigan accepting new patients
    Ann Arbor Michigan 48109 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Paradromics
Links
Paradromics Clinical Study Sign up for this study
ID
NCT07357428
Study Type
Interventional
Participants
Expecting 2 study participants
Last Updated