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New treatment option for Amyotrophic Lateral Sclerosis
Official title Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
ClinicalTrials.gov ID: NCT07357428
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- 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.
You likely 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...
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.