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The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assistive Robotic Arm | Device | The intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant. | 3-months following first use of the assistive device |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Device-Related Adverse Events (AE) | Up to 72 months after enrollment | |
| Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS) | From enrollment, every 3 months, up to 72 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States |
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| Label | URL |
|---|---|
| Neuralink Website | View source |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D000690 | Amyotrophic Lateral Sclerosis |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).
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|
| Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score | From enrollment, every 3 months, up to 72 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |