Clinical Trials
Clinical Trials
We are currently recruiting for the following two clinical trials.
When paralysis makes it hard to talk, it can feel like your voice is cut off from your thoughts. The Connect-One Clinical Study is testing a brain-computer interface (BCI), called Connexus® BCI, to see if it can help rebuild the link between what you want to say and your ability to speak.
Connect-One is the first study to test the Connexus BCI in people. After surgery to place the device, the Connexus BCI reads from the brain area that controls speech movement and is designed to turn brain signals into text, a digital voice, or commands for a phone or computer.
Participants will meet with the Connect-One Team several times a week to help adjust the system for their communication needs. Support by a dedicated team will continue throughout the 6-year study.
Connexus BCI is an investigational device limited by United States law to investigational use.
Study Overview:
Site Investigator: Dr. Matthew Willsey
Location: University of Michigan, Ann Arbor
Objective: To test a brain computer interface system, aimed at restoring communication
Eligibility:
Are an adult between 22 and 75 years old. • Are diagnosed with a progressive disease (like Amyotrophic Lateral Sclerosis (ALS)) or an injury that affects muscles or nerves (like a brainstem stroke).
Have trouble speaking, such as slurred speech (dysarthria) or loss of control over speech muscles (anarthria).
Can communicate well enough to agree to join the study and share experiences.
Can read and understand English.
Live within 4 hours of Ann Arbor, MI.
You do not need regular MRI scans.
Have no other implanted devices.
Other eligibility criteria not included
Participant Benefits:
Opportunity to be at the forefront of neural technology
Contribute to potentially life-enhancing research
Disclaimer: We cannot promise that the system will restore communication or mobility
Contact Us:
Contact: Study Team
Email: ClinicalTrialsBCI@med.umich.edu
Website: https://umhealthresearch.org/studies/HUM00271193 or https://www.paradromics.com/clinical-study
Please include “Brain-Computer Interface Study” in the subject line.
Investigational Brain-Computer Interface for Motor/Speech Restoration
Join an Innovative Clinical Trial at the University of Michigan. Are you living with paralysis of your arms and legs or unable to produce speech due to spinal cord injury, brainstem stroke (potentially including but not limited to locked-in syndrome), amyotrophic lateral sclerosis, progressive muscle atrophy, adult-onset spinal muscle atrophy, or muscle dystrophy?
The purpose of this study is to obtain preliminary device safety information for an investigational device that reads information from your brain and uses it to control computers, devices, generate text, and other things.
Study Overview:
Led By: Dr. Matthew Willsey
Location: University of Michigan, Ann Arbor
Objective: To test a brain computer interface system, aimed at restoring communication and movement.
Eligibility:
Paralysis of the arms and legs or difficulty producing speech from spinal cord injury, brainstem stroke (potentially including but not limited to locked-in syndrome), amyotrophic lateral sclerosis, progressive muscle atrophy, adult-onset spinal muscle atrophy, or muscle dystrophy.
Must be willing to commit to 13 months of participation
Must be willing to help test the system 2-3 times per week.
Must live within a 3-hour drive from Ann Arbor, MI
Other eligibility and exclusionary criteria are available upon request.
Participant Benefits:
Opportunity to be at the forefront of neural technology
Contribute to potentially life-enhancing research
Disclaimer: We cannot promise that the system will restore communication or mobility
Contact Us:
Contact: Study Team
Email: ClinicalTrialsBCI@med.umich.edu
Please include “Brain-Computer Interface Study” in the subject line.