Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Connexus Brain-Computer Interface.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Stroke, Tetraplegia/Tetraparesis. Basic parameters: 22 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
Overview
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.
Interventions
- Device Connexus Brain-Computer Interface
The Connexus Brain Computer Interface is an implantable brain-computer interface.
Primary outcome measures
- Primary Safety: Number of Subjects With Device Related Adverse Events [Time frame: Up to 12 months post-implant]
Secondary outcome measures (1)
- Long-Term Safety: Number of Subjects With Device Related Adverse Events [Time frame: Up to 6 years post-implant]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 3 centers
- University of California, Davis — Sacramento
- Massachusetts General Hospital — Boston
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT07357428 · PRT-1014