Trials / Recruiting
RecruitingNCT07357428
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (estimated)
- Sponsor
- Paradromics · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Amyotrophic Lateral Sclerosis
- Neuromuscular Disease
- Stroke
- Tetraplegia/Tetraparesis
- Cervical Spinal Cord Injury
- Dysarthria
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Connexus Brain-Computer Interface | The Connexus Brain Computer Interface is an implantable brain-computer interface. |
Timeline
- Start date
- 2026-03-31
- Primary completion
- 2027-05-01
- Completion
- 2032-01-01
- First posted
- 2026-01-22
- Last updated
- 2026-04-14
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07357428. Inclusion in this directory is not an endorsement.