Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Michigan | OTHER |
| University of California, Davis | OTHER |
| Massachusetts General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connect-One | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connexus Brain-Computer Interface | Device | The Connexus Brain Computer Interface is an implantable brain-computer interface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety: Number of Subjects With Device Related Adverse Events | Device Related Adverse Events: Number of subjects with device-related adverse events | Up to 12 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Long-Term Safety: Number of Subjects With Device Related Adverse Events | Device Related Adverse Events: Number of subjects with device-related adverse events | Up to 6 years post-implant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paradromics Clinical Team | Contact | (512) 559 4120 | clinical-team@paradromics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
Not provided
| Label | URL |
|---|---|
| Paradromics Clinical Study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D009468 | Neuromuscular Diseases |
| D020521 | Stroke |
| D011782 | Quadriplegia |
| D004401 | Dysarthria |
| D013060 | Speech |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001184 | Articulation Disorders |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
Not provided
Not provided