This is a first in human trial in five individuals, to evaluate the safety of a device to record brain activity without open brain surgery. Additionally, the trial will evaluate the ability of the device to transmit brain signals for one year after implantation. Although not the purpose of this trial, devices such as these may be used to control assistive technology that can perform activities for individuals who are unable to use their arms. If included in this trial, the Stentrode™ device, a small metallic mesh tube with electrode contacts, will be placed into a blood vessel of the brain. Participants will be monitored for adverse events over 12 months. There is no control group in this study.
Ischemia
Non-traumatic
Traumatic
Type
Details
Placement of the device will occur via a short surgical procedure, involving a small skin incision in the neck, where the Stentrode™ device will be placed in a blood vessels in the brain. Participants will be monitored for adverse events, brain activity signal quality, and Stentrode™ performance over 12 months.
Main benefits
General health
Additional benefits
Mechanism of action
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn moreWings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more