Metformin for Motor and Cognitive Improvement in Children with Cerebral Palsy: A Feasibility Study
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Has your child been diagnosed with cerebral palsy? Your child may be eligible to participate in a randomized controlled clinical trial that will investigate the effectiveness of a medication called metformin, and whether it helps to improve your child’s movement and thinking skills.
We want to conduct a randomized controlled clinical trial to see if it would be possible to do a bigger study that would test the effectiveness of a drug called metformin, and whether it helps improve motor skills (i.e. controlled body movements) and thinking skills when compared to doing physiotherapy alone in children with cerebral palsy (CP), when taken for 16 weeks. Participants will be placed into one of two groups based on chance (50/50 chance). The 2 groups in this study are: 1) metformin and 2) placebo. A placebo is a pill that is made to look like the drug being studied, but it does not have any medicine in it. This study will take place at two different places in Toronto: 1) Holland Bloorview Kids Rehabilitation Hospital (Holland Bloorview) and 2) the Hospital for Sick Children (SickKids).
- Darcy Fehlings, MD (Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON)
- Donald J. Mabbott, PhD (The Hospital for Sick Children, Toronto, ON)
Who can participate
We are looking for children between 5-12 years old who:
- Have Bilateral Spastic CP
- Gross Motor Function Classification Scale (GMFCS) level II- V
- Able to consume tablets either whole or crushed, orally or through a gastrostomy tube
- Born prematurely (less than 37 weeks gestation)
- Able to communicate (verbal or non-verbal) pain or discomfort
- Have not had orthopedic surgery in the past three months
- Have no treatment or planned treatment involving diuretics
- Have not been part of another clinical intervention in the past three months
- Other safety criteria
- CHILD BRIGHT Network – funded by the Canadian Institutes of Health Research (CIHR)
- The Hospital for Sick Children Foundation
- Holland Bloorview Kids Rehabilitation Hospital Foundation
- Three to Be Foundation
This is a 40 week (10 month) randomized controlled clinical trial that will take place at Holland Bloorview and SickKids. The trial involves a screening visit, baseline visit, a 16 week intervention period, along with a follow-up visit about 6 months later. Your child will have a 50/50 chance of being randomly assigned (randomized) to either metformin or placebo. You and your child will first be asked to come in for a screening session; through talking with you and your child and completing some assessments, we will determine if your child meets the eligibility criteria.
There will be 10 study visits at Holland Bloorview and 3 study visits at SickKids. During the period that your child is taking the study pill, your child will also receive active physiotherapy twice a week for 16 weeks with a trained research physiotherapist (PT) at Holland Bloorview. If willing, your child will also have 3 pictures of their brain taken at SickKids. Furthermore, your child will complete thinking tests 3 times and questionnaires 2 times at SickKids.
Participants will be reimbursed for parking and/or TTC expenses for each study visit to Holland Bloorview and/or SickKids. Participants will also receive a $100 gift card 3 times throughout the study in recognition of their time commitment.
Interested in participating?
If you are interested in participating in this study or have additional questions, please contact Nisha Kapil at 416-425-6220 ext. 6488 or firstname.lastname@example.org. Contacting us does not obligate you or your child to participate in the study.