RECRUITING

Precise Robotically IMplanted Brain-Computer InterfacE

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Conditions

Tetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; Paralysisspinal cord injury, ALS, brain computer interface, BCI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PRIME: an Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for the Control of External Devices

Quick Facts

Study Start:2024-01-09
Study Completion:2031-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06429735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Life expectancy ≥ 12 months.
  3. * Ability to communicate in English
  4. * Presence of a stable caregiver
  5. * Moderate to high risk for serious perioperative adverse events
  6. * Active implanted devices
  7. * Morbid obesity (Body Mass Index \> 40)
  8. * History of poorly controlled seizures or epilepsy
  9. * History of poorly controlled diabetes
  10. * Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
  11. * Acquired or hereditary immunosuppression
  12. * Use of smoking tobacco or other tobacco products
  13. * Psychiatric or psychological disorder
  14. * Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
  15. * Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Neuralink Clinical Team
CONTACT
(877) 398-4465
clinical-team-ct@neuralink.com

Principal Investigator

Francisco Ponce, MD
PRINCIPAL_INVESTIGATOR
Barrow Neurological Institute

Study Locations (Sites)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States

Collaborators and Investigators

Sponsor: Neuralink Corp

  • Francisco Ponce, MD, PRINCIPAL_INVESTIGATOR, Barrow Neurological Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09
Study Completion Date2031-01

Study Record Updates

Study Start Date2024-01-09
Study Completion Date2031-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Tetraplegia/Tetraparesis
  • Quadriplegia
  • Cervical Spinal Cord Injury
  • Amyotrophic Lateral Sclerosis
  • Quadriplegia/Tetraplegia
  • Tetraplegic; Paralysis