Explanation of examination components: The Utrecht Neuroprosthesis

In the Neuroprosthesis project, we are working on a new method of communication for people with a locked-in state caused by, for example, a brainstem infarction or ALS. For this purpose, we use an implant that converts brain signals into a button press for a computer. Below, we explain what the components of the research entail.

Content of the research

In advance

Participation in the Neuroprosthesis project is only possible if you meet our criteria. The most important ones are:

• Age 18-75 years
• Locked-in status (severe paralysis with communication problems)
• Some reliable communication possible, for example by means of blinking.
• No intellectual disability

Prior to the study, researchers and doctors will visit you at home to discuss the study and the (additional) criteria with you. If you are able and willing to participate in the Neuroprosthesis project, a consent procedure will follow these visits. Participation in the Neuroprosthesis project will not affect your potential treatment. 

We may ask you to perform a small task while you are in the scanner. Examples of tasks include making hand gestures, pronouncing sounds, or imagining touch or movement. However, other tasks are also possible. Before you enter the scanner, the researchers will clearly explain what you need to do. You may also ask questions beforehand if you do not understand something. While you are in the scanner, you will look at a screen through a small mirror. On this screen, you will see instructions for the task. Sometimes we use a special device to measure, for example, your finger or mouth movements. If you do not find this comfortable, please let us know. 

How is the research conducted?

The study consists of several components. These are briefly summarized below. In the first stage (approx. 2 months), we will visit you at home several times to go through questionnaires and practice ‘tasks’. We will also assess whether you are mentally and physically fit enough to participate in the study. This will be followed by hospitalization (UMC Utrecht, approximately 7-9 days), during which you will receive the following in succession:

• a functional MRI scan to determine the location where the electrodes need to be inserted under the skull
• an operation in which the electrodes are inserted under the skull
• a CT scan to check the position of the electrodes
• a number of tests to determine which of the electrodes works best
• an operation in which the best electrodes are connected to the transmitter, and in which the transmitter is placed under the skin on the chest
• a number of tests for setting up the transmitter

Once you are back home, the training and user phase begins (1 year, extendable to 2 years), during which you are taught to operate the computer as effectively as possible using your brainwaves, and during which you can use the UNP yourself to communicate. During this phase, we will visit you regularly to check on your progress, practice with you, configure the device as optimally as possible, and resolve any issues. Additionally, we will administer questionnaires regularly to determine how useful the UNP is as an aid in daily life. We also regularly record brain signals to see whether or not they change over time. 

Pros and cons of participation

Your participation in this study will not contribute to the cure or improvement of your paralysis. However, we do expect that you will have a new way to communicate. This may prove to be a better way for you to communicate than the way you currently do. However, there is a chance that it will require quite a lot of practice, energy, and perseverance to get the UNP to work properly, or that it may not work at all. It may also take a lot of time to try different settings before it works well. We will do our best to keep you motivated during this process.

Disadvantages of participating in this study include hospitalization (approximately 7-9 days) and undergoing surgery. As with any surgery, complications may occur. You will be informed by a doctor during the first stage about the risks specific to you.

In addition, we will visit you regularly at home before and after the implantation to administer questionnaires, practice with you, and make any necessary adjustments to the system. Furthermore, we regularly record brain signals, during which you will need to perform some short tasks. These visits will be scheduled as much as possible in consultation with you and your caregivers. How often we visit you depends on the stage of the study.

Furthermore, it is important to know that, after implantation of the electrodes and the transmitter, treatments based on so-called ‘diathermy’ are no longer possible. Additionally, it is not possible to undergo an MRI scan after the implantation of the electrodes and the transmitter. If new information regarding your health condition is discovered during the procedure (for example, during the functional MRI scan of the brain), you, your treating physician, and/or your general practitioner will be informed.

What happens to your data?

A few other people may see your data. These people check whether the research is sound and reliable. You can find more information about this in the VWS brochure *Medical-scientific research; General information for the research subject*.

We would like to ask for your permission to publish the data we obtain from this study and to use it for related research conducted in the future. Your privacy will, of course, remain protected in this process.

We would also like to ask for your permission to provide the data we obtain from this study to the manufacturer (locations in Europe and the United States) of the implanted parts, so that they can publish the data or use it for related research. The manufacturer uses secure internet storage. Here too, we will ensure that your privacy remains protected.

Your research data will be retained for some time after the completion of the study. This data will be coded so that it is not directly linked to your name. We may be able to use this data to conduct another study within the same research area at a later date. We will contact you again regarding this. If you do not wish to be contacted again, we will of course respect that. After 20 years, all coded research data will be destroyed.