This study involves two-visit sessions that include an MRI, brain stimulation, and movement assessment at the University of Minnesota in Minneapolis, MN. Families will receive a $100 payment card upon completion of their participation.
Your baby may be eligible if:
- They are 3-24 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
Motivation for the 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 (MRI scan) 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.
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 pulses of energy to the top of your baby's head
- Learn about your baby's movements as the researcher uses an infant movement assessment
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
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.
Frequently Asked Questions
What is the clinical importance of this study?
To determine how changes in the brain relate to sensorimotor development in children with perinatal stroke. Findings from this study may inform future therapies and treatment options for infants with brain injuries.
How long is the study?
The study consists of two 2-3 hour visits. The first visit includes an MRI imaging scan. The second visit includes movement/ sensory behavior testing and the TMS brain connectivity testing.
Is there a cost to participate?
No, there are no costs to participate. Families will receive a $100 payment card upon completion of their participation.
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/
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.
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.
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.