Brain Computer Interface for Functional Recovery from Brain Injury

Purpose of the Study

The goal of this study is to find out whether different parts of the brain can be trained to work together using low-level stimulation on the surface of the brain. We hope doing this might help people recover from brain injury. This study will be done over 3-4 years in about 15 subjects.

Paticipants of the study undergo surgery to place electrodes on the surface of their brain as part of regular care for epilepsy. Also as part of their regular care, participants will undergo stimulation of the brain with small amounts of electrical currents given through the electrodes to "map" the motor and language parts of the brain. The electrodes will record the electrical activity of the brain over 7-10 days.The decision to place the electrodes on the brain, and where and how long they are applied, is part of regular care.

If participants agree to be in this research study, they will have one session that takes 4-12 hours in addition to regular care during their stay at the Epilepsy Center. The research testing session occurs in between the two surgeries to place and remove the electrodes. As part of the testing sessions:

• Participants will watch two 30-minute videos that ask them to do things like move their fingers or name ordinary objects or animals. During the tests, adhesive pads are placed on the forearm or cheek to record muscle activity. We might also record voice responses. While participants are taking the tests, they may take a break or stop at any time.
• After finishing the video tests, a couple of the electrodes will be stimulated for 4-12 hours. The stimulation will be at a lower level than the stimulation used for regular care. We may leave on the adhesive pads to record muscle activity during this testing.
• We will repeat the stimulation used to map motor or language function in regular care. This stimulation will take place for about five minutes. We will only repeat this higher-level stimulation at a few electrodes, including the electrode used for low-level stimulation. This higher-level stimulation may make a participant's hand or face twitch during the stimulation.

In addition to the testing sessions, we will review each participant's medical records and record information about the location of the electrodes, which may include:

• X-rays or other images made after the electrodes are put in by a surgeon;
• Results of MRI and EEG before surgery; and
• Abnormal tissue findings found by a later surgery.

We may share the results of the stimulations, including photos and videos if participants allow them to be taken, with other researchers or show them in publications. We will not have pictures of the face or any other information that could identify participants in publications.

We will label the study information with a code, and keep the key that links participant identity with a study code for up to five years after the study ends. After that, we will destroy the key, and keep the results of the study without any information that identifies participants in order to possibly look at the study information in the future.

For more information, or to participate in this study, please contact the coordinator or investigators:

Principal Investigator:

Jeffery G. Ojemann, MD
Professor, UW Department of Neurological Surgery
Phone: (206) 987-3925

Sub–Investigators:

Shahin Hakimian, MD
Stavros Zanos, MD
John Miller, MD, PHD
Mark Holmes, MD
Mathew Edwardson, MD

Research Coordinator:

Alana Clark, BA
Department of Neurological Surgery
Phone: (206) 744-9364

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