## Protocol Section
### Identification Module
**NCT ID:** NCT06429735

**Acronym:** PRIME

**Brief Title:** Precise Robotically Implanted Brain-Computer Interface

**Official Title:** PRIME: An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for the Control of External Devices

#### Organization Study ID Info
**ID:** N1-EFS-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Neuralink Corp
### Status Module
#### Completion Date
**Date:** 2031-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Neuralink Corp

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.

### Conditions Module

**Conditions:**

- Tetraplegia/Tetraparesis

- Quadriplegia

- Cervical Spinal Cord Injury

- Amyotrophic Lateral Sclerosis

- Quadriplegia/Tetraplegia

- Tetraplegic; Paralysis

**Keywords:**

- spinal cord injury, ALS, brain computer interface, BCI

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 3

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Implantation of the N1 Implant by the R1 Robot.

**Intervention Names:**

- Device: N1 Implant

- Device: R1 Robot

**Label:** Neuralink N1 Implant and R1 Robot

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Neuralink N1 Implant and R1 Robot

**Description:** The N1 Implant is a type of implantable brain-computer interface

**Name:** N1 Implant

**Other Names:**

- Neuralink N1 Implant, N1, Telepathy, Link

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Neuralink N1 Implant and R1 Robot

**Description:** The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

**Name:** R1 Robot

**Other Names:**

- R1, Neuralink R1 Robot

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Device-Related Adverse Events (AE)

**Time Frame:** 12 months post-implant

**Measure:** Procedure-Related Adverse Events (AE)

**Time Frame:** 12 months post-implant

#### Secondary Outcomes

**Measure:** Device-Related Adverse Events (AE)

**Time Frame:** Up to 72 months post-implant

**Measure:** Procedure-Related Adverse Events (AE)

**Time Frame:** Up to 72 months post-implant

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver

Exclusion Criteria

* Moderate to high risk for serious perioperative adverse events
* Active implanted devices
* Morbid obesity (Body Mass Index \> 40)
* History of poorly controlled seizures or epilepsy
* History of poorly controlled diabetes
* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
* Acquired or hereditary immunosuppression
* Use of smoking tobacco or other tobacco products
* Psychiatric or psychological disorder
* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

**Maximum Age:** 75 Years

**Minimum Age:** 22 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinical-team-ct@neuralink.com

**Name:** Head of Clinical

**Phone:** 818-527-2710

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Phoenix

**Contacts:**

***Contact 1:***

- **Name:** Francisco Ponce, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Barrow Neurological Institute

**State:** Arizona

**Status:** RECRUITING

**Zip:** 85013

#### Overall Officials

**Official 1:**

**Affiliation:** Barrow Neurological Institute

**Name:** Francisco Ponce, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** https://neuralink.com/

**URL:** https://neuralink.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000057177

- Term: TDP-43 Proteinopathies

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M14632

- Name: Quadriplegia

- Relevance: HIGH

- As Found: Quadriplegia

- ID: M15415

- Name: Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M18879

- Name: Motor Neuron Disease

- Relevance: HIGH

- As Found: Lateral Sclerosis

- ID: M4024

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Amyotrophic Lateral Sclerosis

- ID: M13157

- Name: Paralysis

- Relevance: HIGH

- As Found: Paralysis

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M28759

- Name: TDP-43 Proteinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T349

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Amyotrophic Lateral Sclerosis

- ID: T4699

- Name: Primary Lateral Sclerosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000016472

- Term: Motor Neuron Disease

- ID: D000000690

- Term: Amyotrophic Lateral Sclerosis

- ID: D000010243

- Term: Paralysis

- ID: D000011782

- Term: Quadriplegia

### Misc Info Module

- Version Holder: 2024-05-31
