Before Participating (caregivers complete for minors)
- Review study information and sign medical records release forms
- Complete a 15-minute medical history phone survey
- 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
- Review the study with the researcher and ask any questions you might have
- Sign consent/assent forms that say you understand the study and want to participate
Visit 1 (1 hours) on U of M Campus
- We’ll take a picture of your brain using an MRI machine.
Visit 2 (3 hours) on U of M Campus (Visit 1 can be done on the same day as Visit 2 if preferred)
- Help us find the hotspot in your brain that talks to your muscles using a cool brain stimulation machine.
- Play a computer game that allows you to move your finger to trace different patterns
- Perform the same game while your brain gets stimulated (this time with a much smaller machine!)
- Help our machine find the hotspot in your brain again.
- Tell us what you think of the study!
University of Minnesota
2021 Sixth Street SE
Minneapolis, MN 55455
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 do the researchers hope to learn?
If providing a particular form of non-invasive brain stimulation will help increase brain activity for children diagnosed with hemiparesis (weakness on one side of the body). This research is important to the future goal of bringing non-invasive brain stimulation into clinics that are specialized and targeted for each individual.
How will participating in this study help children with cerebral palsy?
This research helps us explore how stimulation affects brain function in children with cerebral palsy so that we can design better interventions that will help a greater number of children. Our goal is that these therapies will increase hand strength and function, which in turn could improve their quality of life by making everyday tasks more manageable.
How will I benefit from participating?
You may experience a temporary improvement in hand skill, however we do not expect these changes to last in a one-time session.
What is brain stimulation?
Brain stimulation is a way to measure or influence brain activity. The types of brain stimulation in this study are transcranial Direct Current Stimulation (tDCS) and transcranial magnetic stimulation (TMS). Both of these forms are applied to the top of the head.
Do I have to take a break from other activities/therapies in order to participate?
No, you can continue participating in your regular activities or physical therapy during the study.
Do all children receive the real intervention?
To learn about the effects of brain stimulation, there will be a control or “sham” group in this study. This group will not receive real stimulation. Therefore, you may not receive the real stimulation.
What are the risks with tDCS brain stimulation?
- 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 a 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.
Does tDCS brain stimulation hurt?
There may be some itchy or tingling sensations during the application. Participants are asked to tell us immediately if the stimulation feels painful. We will also assess pain at the testing component of each session. Adjustments will be made or application will be discontinued.
How long is the actual application of the tDCS and hand therapy?
The application of the tDCS lasts for 20 minutes.
What are the characteristics of kids you are working with on this study?
Participants are 7-21 years old. In addition:
- Had a stroke before turning 1-year old
- One side of the body is not as strong as the other side (hemiparesis)
- Able to move the affected hand partially
- Able to follow simple instructions
- No evidence of seizure activity within the last 2 years
Does this cost money to participate?
There is no charge for you to be involved, you will be compensated $50 for participating in this study.