Brain-Controlled Device for Quadriplegia
This research study is developing a brain-controlled medical device, called a brain-machine interface, for people with quadriplegia (paralysis affecting all four limbs). The device, called Neural Prosthetic System 2 (NPS2), uses tiny implants in the brain to help you control external devices like a computer cursor or robotic arm with your thoughts. Researchers want to see if patients can successfully control these devices and if the implants remain safe for up to nine years. This study is looking for five participants, aged 22-65, who have a high spinal cord injury, can speak English, and meet other health requirements. The study's current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 5 participants. The study is investigating the use of a device called Neural Prosthetic System 2 (NPS2).
- What's involved
- You would need to travel up to 60 miles to study locations up to five days per week. A caregiver would need to monitor you daily for surgical site complications and behavioral changes.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure patient control over devices and the absence of infection or irritation for nine years after the array implantation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sensory Motor Transformations in Human Cortex
At a glance
Conditions
Where it's being run
4 sites across 2 statesStudy leadership
- Richard A Andersen, PhD · PRINCIPAL_INVESTIGATOR · California Institute of Technology
- Charles Liu, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Southern California, Rancho Los Amigos Rehabilitation Center
- Dan Kramer, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
- Luke Bashford, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Patient control over the end effector (virtual or physical)Nine years after array implantation
The primary effectiveness objective of this study is to evaluate the effectiveness of the NPS2 in controlling virtual or physical end effectors. Signals from posterior parietal cortex will allow the subject to control the end effector with accuracy significantly greater than chance; the subject will be able to perceive and discriminate ICMS above the level of chance; and,incorporating stimulation will improve the subject's control over the end effector. We will evaluate the effectiveness of the NPS2 primarily by calculating the accuracy of the subjects' control over the end effector with and without ICMS, and comparing these different accuracies to the chance level, and to each other. Each subject will serve as his or her own control.
- Absence of infection or irritationNine years after array implantation
The primary objective of this study is to evaluate the safety of the NPS2. Implantation will not be associated with infection or irritation, and that the serious adverse event rate will not rise above 1%. We will evaluate the safety of the NPS2 by inspecting the subjects' scalps for evidence of reddening or discharge, by performing regularly scheduled neurologic history and physical exam, and by obtaining feedback from the subjects. The condition of the area will be compared with its condition on previous visits, history will be obtained regarding new symptoms and neurological and physical exam will be compared to baseline exams.