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

Paradromics

Status

Enrolling

Conditions

Stroke

Dysarthria

Amyotrophic Lateral Sclerosis

Cervical Spinal Cord Injury

Tetraplegia/Tetraparesis

Neuromuscular Disease

Treatments

Device: Connexus Brain-Computer Interface

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07357428

PRT-1014

Details and patient eligibility

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.

Enrollment

2 estimated patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

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.