Infant Research Study
One in 2,300 babies have a stroke or bleeding in the brain. These babies are at high risk of developing difficulty moving due to changes in the brain. To provide treatment when it will potentially be most helpful, we first need to understand how the brain changes in babies after they have a stroke.
Using pictures and brain stimulation that does not require surgery, we will study these baby's brains and how they move. Both the picture and the stimulation have been studied in older children who also had a stroke around the time that they were a baby. Looking at how the brain develops at this young age will help understand brain function in babies with stroke and create treatments with the goal to improve the baby's movement.
Infant Stroke Study
The study consists of two 2-hour visits at the Universtiy of Minnesota in Minneapolis, MN. Families will receive $25 after the first visit and $75 after the second, paid by Visa gift cards.
The babies are included if:
- They are 3-12 months old
- They had a stroke or bleeding in the brain confirmed by the doctor
- They are either seizure-free or have documented seizures which are now controlled on anti-seizure medications
- They have no other neurologic or genetic diagnosis that could influence movements
For more information please contact the Gillick Pediatric Laboratory:
Dr. Sam Nemanich, PhD
Before Participating (caregivers complete)
- Review study information and sign medical records release form
- Medical records will be obtained and reviewed to determine eligibility for the study
- If eligible, the study coordinator will work with the family to schedule the visits
Enrollment and Brain Scan (one 2-hour visit) on U of M Campus
- Review the study with the researcher and ask any questions you might have
- Sign a consent form that says you understand the study and want to participate
- Have a picture of your baby's brain taken in an MRI machine while your baby sleeps
Stimulation and Movement Assessment (one 2-hour visit) on U of M Campus
- Hold your baby while the researcher applies brain stimulation to the top of your baby's head
- Learn about your baby's movements as the researcher uses an infant movement assessment
Frequently Asked Questions
Where is this study taking place?
Both the magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) will be performed at the University of Minnesota at two different centers.
- Center of Magnetic Resonance Research (CMRR): https://www.cmrr.umn.edu/
- Clinical and Translational Science Institute (CTSI): http://www.ctsi.umn.edu/
How do you use a 5-minute video to know baby’s motor development?
Infants have typical and distinct spontaneous “general movements” from before birth through to 20 weeks post term. The General Movements Assessment is used to identify absent or abnormal movements. This 5-minute assessment provides information for potential needs for intervention to support the growth of your baby.
Is there radiation during (Magnetic Resonance Imaging) MRI scanning?
Radiation is not used in MRI scanning.
How do you know the TMS is non-invasive?
The technique of TMS is non-invasive, meaning there is no surgical procedure to do this assessment. We will place a TMS coil on the baby’s head, deliver a magnetic pulse, and measure the response in arm muscles. This will help us know how active the brain is in the area that controls arm movement. TMS pulses are able to reach the brain (central nervous system) from outside of the skull.
Does TMS cause long-term side effect to infants?
There are no reported long-term side effects of TMS in children. Dr. Gillick’s previous work found that in pediatric populations there are no related long-term side effects in children who receive TMS assessment or intervention.
How do you know where to place the TMS stimulator?
The TMS pulses are sent from a coil gently placed on the baby’s head. (see picture below). The area that delivers the magnetic pulses is in the center of the coil (see picture) allowing us to target a small area of the brain. In addition, we use magnetic
resonance imaging (MRI) to capture pictures of the baby’s brain. We convert these pictures to 3-dimensional (3D) brain pictures on a computer. This 3D image tracks and confirms the location of the coil.
What if I want to stop participating in any part of the study?
Your participation is voluntary and you can stop participating in this study at any time. To help you prepare for your baby’s visit, we will introduce our three assessments (taking brain pictures, delivering brain pulses, and assessing general movements) before your visit. We will walk through the procedures with you again during your visit. You can still decide to stop participation or only participate in part of the study after receiving all the information.
What is the benefit of participating in this study?
The purpose of this study is to work with families to understand more about a baby’s brain development after early brain injuries and how that development influences movement. The data from this study provides the foundation for future studies aimed exploring interventions during early stages of development to benefit this infant population.
Can we get the data (or report) from this study?
We will provide you with an individual report after the completion of this study. We will also inform you of any publications that result from this study.
Does it cost anything to participate in this study?
There is no cost to participate. The study consists of 2 two-hour visits. Families will receive $25 after the first visit and $75 after the second visit, paid by Visa gift cards.
Can I be with my baby the whole time?
When taking the brain pictures, your baby will be in the scanning area while you are watching in the console room. There is a big window between the two areas (see the picture below). However, we have one investigator who stays in the room with your baby throughout the scanning. Except for this part, you will be with your baby all the time.
University of Minnesota
2021 Sixth Street SE
Minneapolis, MN 55455
Click here for map
From Highway I-94 take the Huron Boulevard exit and go north:
- Proceed ~3 blocks down Huron Boulevard to Washington Avenue.
- Continue straight across Washington Avenue.
- Continue straight across University Avenue onto SE 23rd Avenue.
- Proceed ~3 blocks to SE 6th Street.
- Turn left on 6th St SE.
- The CMRR is the second building on the right (2021)
On street parking is located on the east side of the CMRR building. Enter from 6th St SE, under skyway. Parking permits are available from the front desk.
Delaware Clinical Research Unit (DCRU)
717 Delaware Street SE
Minneapolis, MN 55455
Click here for a map
From Highway I-94 take the Huron Boulevard exit and go north. Then:
- Left on Fulton Street SE
- Right on Oak Street SE
Cross Delaware Street and make a left into the entrance of parking lot (at the back of the building). We will meet you at the back entrance of the 717 Delaware Building.
This Study is Funded by:
- Cerebral Palsy Alliance AACPDM
- U of M Academic Health Center Seed Grant
- MnDrive Fellowship