Brain Stimulation & Hand Training
This study is for children and young adults (8-21 years) who have had a stroke before, during or up to one year after birth and as a result have weakness on one side of the body (hemiparesis). The focus of this study is specifically on the function of the weaker hand.
After a stroke early in life, the brain can develop in different ways. This means that the side of the brain with the stroke may maintain control of the weaker hand or the side of the brain without the stroke may take-over and control the weaker hand. We can test for these changes in the brain with one form of painless, non-invasive brain stimulation. For this study, we are studying children whose stroke side of the brain has maintained control to the weaker hand.
Research using brain stimulation on the outside of the head (non-invasive) has shown improvements in recovery of motor function. In this research study we are combining a form of non-invasive brain stimulation called Transcranial Direct Current Stimulation (tDCS) with an intervention for hand function called bimanual therapy.
Using tDCS for brain stimulation, the brain cells that were inactive due to stroke have the potential to become active and contribute to improving function of the weaker hand. During bimanual intervention for rehabilitation, the stronger hand will work with the weaker hand to learn movements and encourage coordination between the two hands
The goal of this study is to determine if combining bimanual intervention and tDCS has a greater impact on improving hand function than no intervention. This study is an open-label design meaning that every participant will receive bimanual intervention and tDCS.
The study includes a 10-day camp (3 total hours/day), four pre-test visits, one post-test visit, and a follow-up phone call 1 week after completion of the study. Pretest visits 1-3 can be done over video conferencing. Pretest visit 4 will be in person at the University of Minnesota. Visits will occur at the University of Minnesota, Minneapolis
Camp dates: Summer 2017
In addition to the diagnosis of hemiparesis, participants must be able to:
- Perform activities with the weaker hand (such as squeezing)
- Follow and respond to simple directions
- Have no evidence of seizure activity within the last 2 years
- Able to give informed consent
- Deomonstrate a brain development pattern where the stroke side of the brain has maintained connections to the weaker hand. This is assessed with one of our testing tools called Trancranial Magnetic Stimulation (TMS)
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
Enrollment (one 45 minute video conference)
- 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
Pre-Test Visits 1,2 and 3 (30 minute video conferences)
- Participate in weekly video phone call assessments (30 minutes maximum) for testing including asking you questions and a test of moving wooden blocks
Pre-Test Visit 4 (3 hours) on U of M Campus
- Help us find the hotspot in your brain that talks to your muscles using a cool brain stimulation machine.
- Complete testing to learn how your muscles work and how you move
Intervention (ten 3-hour visits) on U of M Campus
- Participate in fun activities while your brain gets stimulated (this time with a much smaller machine!)
Post-Test (3-hour visit) on U of M Campus
- Repeat the activities from the pre-test to show us if your hand moves differently then before the study
- Help our machine find the hotspot in your brain again
- Tell us what you think of the study!
Follow-Up (30 minute videoconference)
- Phone call to see how you are doing after the study and repeat some of our questions
Center for Magnetic Resonance Research (CMRR)
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.
Clinical & Translational Science Institute (CTSI) and Center for Neurobehavioral Development (CNBD)
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 combining non-invasive brain stimulation with other therapies will help increase hand function 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 in order to improve hand function beyond what rehabilitation therapies alone can provide.
How will participating in this study help children with cerebral palsy?
This research helps us explore ways to offer children with cerebral palsy therapies that can 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 an improvement in hand strength and control. Changes in the ability to use your hand may help you with activities of daily living skills such as dressing, cutting up food, or job skills.
What is brain stimulation?
Brain stimulation is a way to influence brain activity. The brain stimulation in this study has a long name - transcranial Direct Current Stimulation (tDCS) and is one form of brain stimulation that can be applied to the top of the head.
What type of therapy will I receive?
Bimanual, goal-directed therapy. During bimanual, or two-handed, therapy the child works with both hands. Goal-directed therapy is where we ask questions on what is most important to be able to do in daily life. We then include working on those activities during the therapy sessions. For this study you will receive bimanual, goal-directed therapy for 2 hours/day for 10 days. During a small part of the bimanual, goal-directed therapy you will also receive brain stimulation on top of the head.
Do I have to take a break from other activities/therapies in order to participate?
We encourage participants to take a break in their regular therapies during the two-week camp to receive the optimal benefit, get enough rest, and increase motivation.
Who can participate and do all children receive the real treatment?
For this study we are studying children whose stroke side of the brain has maintained control to the weaker hand. In research we need to be able to compare changes after an intervention in a child to a time without intervention. To learn about changes after intervention, this study is designed where all children will receive the real tDCS and bimanual therapy. The comparison time of "no intervention" will occur prior to coming. Our testing schedule will help us learn about the following:
- Identify how the brain controls the weaker hand 4-6 weeks prior to the start of camp. This will help us know if a child can participate in the camp.
- Weekly video phone call assessments (30 minutes maximum) for testing including surveys and a test of moving wooden blocks. (We will provide the supplies for the wooden block test.)
- Pre-testing the week before camp including an MRI, brain stimulation testing, and hand tasks such as moving blocks, testing how strong the hand is, and seeing how well both hands work together.
- Following camp there is post-testing with brain stimulation and hand tasks.
- One week after camp is over there is a follow-up video call (15-30 minutes) to check and see how your child is doing.
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 is for the first 20 minutes of a 2-hour rehabilitation session, each day for 10 days. Daily appointments will be 3 hours in duration as we have testing we do before and after each tDCS and rehabilitation session (i.e., taking blood pressure and asking question as to how your child is feeling).
What are the characteristics of kids you are working with on this study?
Participants are 8-21 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 the therapy or planned assessments. There is no reimbursement for other personal expenses during the study.
In progress, but not enrolling
This study is funded by:
- Cerebral Palsy Research Foundation
- Foundation for Physical Therapy Magistro Family Foundation Research Grant
- National Institutes of Health - Eunice Kennedy Shriver National Institute of Child Health and Human Development