Frequently Asked Questions

Although the risks of this study are low, and we have established this study with the goal of keeping infants as safe as possible, all studies have risks. We closely monitor each child, in the presence of the family, during each step of the study. We can modify or stop at any point. To date, we have had no serious adverse events (for example, seizure) in any of our studies in over 200 infants and children in over 1,000 sessions. Safety is our primary focus at every juncture of our studies. For parent/legal guardian participants, the primary risk is a breach of confidentiality. We will do everything we can to keep your data safe and secure.

Being in this study will allow you to learn more about the development of your child and their brain. This study will not directly help you or your child—it does not provide a treatment or a therapy. However, your participation in the study may benefit other people in the future by helping us learn more about early changes in children with injury to the brain. You and your child’s participation may also help us develop future interventions to improve brain and movement function.

We want to find out how the brain changes in babies after an early injury to the brain. We are doing this research because an early brain injury has the potential to influence development and movement. To provide early therapies at a time when the brain is still developing and recovering from the brain injury, we first need to understand how the brain may have changed.

This study will take place at the Waisman Center which is located on the University of Wisconsin-Madison campus (1500 Highland Ave., Madison, WI, 53705).

Parents/legal guardians will be able to accompany their child throughout the entirety of the study.

Taking part in research is voluntary. If you decide now to take part, you can choose to leave the study at any time. If you choose to leave the study, your choice will not affect any treatment relationship you or your child have with healthcare providers at UW-Madison, UW Health or any affiliated organizations.

Our findings are usually published in academic journals for other researchers and educators interested in fields related to brain development, rehabilitation, or pediatric neuromodulation to read. Our team may also present results at scientific conferences to clinicians and researchers. We will also share our key results with the communities and families with whom we work, including through plain-language summaries and newsletters. We protect your personal information and protected health information and will never do not publish identifiable information unless we have your specific consent.

During the study, we will create a picture of your child’s brain using Magnetic Resonance Imaging (MRI). To understand how your child’s brain is sending signals to the muscles, we will use non-invasive pulses of energy. We will also assess your child’s movements and behavior. These assessments will be completed over two study sessions at 4-5 different timepoints over the first 2 years of the baby’s life.

We are doing a clinical trial study with children who have had a diagnosis of hemiparetic cerebral palsy with a history of perinatal brain bleed or stroke. We want to progress telehealth and explore how to eventually show that remote neuromodulation therapy could be effective in providing therapy to children with cerebral palsy(CP). Effective remote neuromodulation therapy can provide access to in-person rehabilitation and aid in accommodating mobility and financial challenges. Ultimately, this will contribute to a wider reach in improving quality of life across the lifespan in individuals with CP.

The research study will be conducted over 5 consecutive days. A study monitor team member will bring the active device to your home setting and You will be accompanied by a safety monitor at the place of simulation. You will also be in a videoconference call with another remote study team member who will instruct you through the steps. Each session will last about an hour.

• Headache – the tDCS headband may cause a mild discomfort or headache. The stimulation itself may also cause a mild temporary headache.
• Tiredness – tDCS and the testing series may cause tired feeling.
• Itching, tingling and burning sensation in the area of the electrodes – The tDCS stimulation may cause discomfort at the site of the electrode placement on the head. Proper skin preparation and placement will be followed.
• Skin Redness- The area of electrode placement will be looked at for any prior skin irritation or irregularity. If the skin is intact and the study proceeds and redness still occurs, the electrode placement and contact will be assessed. The area of redness will be monitored at all testing sessions
• Seizure – There have been no reported seizures with the use of tDCS in adults or children. If however, a seizure does occur, medical care is immediately available.